Drugs |
MINERAL IV Injection, compounded by Abrams Royal Pharmacy, Inc.,
Dallas, TX |
Lot number 11142013@74 |
Class I |
Non-Sterility; analytical results found product to contain Sphingomonas
paucimobilis |
Abrams Royal Pharamacy |
Drugs |
All Unexpired Sterile Drug Products, compounded by Abrams Royal
Pharmacy Inc., Dallas, TX |
All unexpired lots of sterile drug products |
Class II |
Lack of Assurance of Sterility |
Abrams Royal Pharamacy |
Food |
Cheese Pre-mix, CF 21-1, in 50 lbs bags, intended to be used in
the manufacture of cheese dip |
Lot # 090313-103, Exp date 3/3/2014; Exp date Lot #091 91 3-1
04, Exp date 3/19/2014; Lot # 093013-105, Exp date 3/30/2014; Lot # 102813-101,
Exp date 4/28/2014; Lot # 112113-107, Exp date 5/21/2014; Lot# 121013-102, Exp
date 6/10/2014; Lot # 012814-102, Exp date 7/28/2014 |
Class II |
Undeclared wheat |
Custom Ingredients LLC |
Food |
Cheese Pre-mix, LG 18-1,in 50 lbs bags, used in the manufacture of
cheese dip |
Lot # 09041 3-1 03, Exp Date 12/4/2013; Lot # 091913-101, Exp
Date 12/19/2013; Lot # 09301 3-1 07, Exp Date 12/30/2013; Lot # 1 0281 3-1 02,
Exp Date 1/28/2014; Lot # 112013-106, Exp Date 2/20/2014; Lot # 121213-102, Exp
Date 3/12/2014; Lot # 012814-101, Exp Date 4/28/2014 |
Class II |
Undeclared wheat |
Custom Ingredients LLC |
Food |
French Onion Dip Pre--mix CJ 7-3, in 50 lbs bags intended to be
used in the manufacture of French onion dip |
Lot # 111413-107, Exp Date 2/14/2014;.Lot # 112513-105, Exp
Date 2/25/2014; Lot # 120213-101, Exp Date 3/2/2014; Lot # 121 113-106, Exp Date
3/11/2014 |
Class II |
Undeclared wheat |
Custom Ingredients LLC |
Food |
Cheese Pre-mix JD 6-4, in 50 lbs bags intended to be used in the
manufacture of cheese dip |
Lot # 100313-103. Exp Date 1/3/2014, Lot # 112013-105, Exp
Date 2/20/2014 |
Class II |
Undeclared wheat |
Custom Ingredients LLC |
Food |
Cheese Pre-mix ACNC, in 45 lbs bags intended to be used in the
manufacture of cheese dip |
Lot# 121213-101 |
Class II |
Undeclared wheat |
Custom Ingredients LLC |
Food |
Chipotle Cheese Pre-mix DA 15-1, in 50 lbs bags intended to be
used in the manufacture of cheese dip |
Lot# 101613-108, Exp Date 1/16/2014; Lot# 110413-106, V
2/4/2014; Lot# 011314-108, Exp Date 4/13/2014 |
Class II |
Undeclared wheat |
Custom Ingredients LLC |
Food |
Monterey Jack Pre-mix EI 20-3, in 50 lbs bags intended to be used
in the manufacture of cheese dip |
Lot# 082913-102, Exp Date 11/29/2013; Lot# 091713-101, Exp
Date 12/17/2014 |
Class II |
Undeclared wheat |
Custom Ingredients LLC |
Food |
All Natural Cheese Pre-mix IA 9-4, in 50 lbs bags intended to be
used in the manufacture of cheese dip |
Lot# 101613-104 |
Class II |
Undeclared wheat |
Custom Ingredients LLC |
Food |
Cheese Pre-mix DRWC, in 50 lbs bags intended to be used in the
manufacture of cheese dip |
Lot# 082013-101, 2/20/2014; Lot# 080813-102, 2/8/2014; Lot#
090413-102, 3/4/2014; Lot# 092413-101, 3/24/2014; Lot# 092513-106, 3/25/2014;
Lot# 093013-104, 3/30/2014; Lot# 100813-107, 4/8/2014; Lot# 103013-101,
4/30/2014; Lot# 120413-103, 6/4/2014; Lot# 011314-101, 7/13/2014 |
Class II |
Undeclared wheat |
Custom Ingredients LLC |
Food |
Cheese Pre-mix JG 9-1, in 50 lbs bags intended to be used in the
manufacture of cheese dip |
Lot# 072913-104, Exp Date 10/29/2013; Lot# 082213-101, Exp
Date 11/22/2013; Lot# 082113-101, Exp Date 11/21/2013; Lot# 091713-103, Exp Date
12/17/2013; Lot# 101613-107, Exp Date 1/16/2014; Lot# 121913-101, Exp Date
3/19/2014 |
Class II |
Undeclared wheat |
Custom Ingredients LLC |
Food |
Cheese Pre-mix JC 9-3, in 50 lbs bags intended to be used in the
manufacture of cheese dip |
Lot# 121713-102 |
Class II |
Undeclared wheat |
Custom Ingredients LLC |
Food |
All Natural Cheese Pre-mix JF 12-1, in 50 lbs bags intended to be
used in the manufacture of cheese dip |
Lot# 100813-109, Exp Date 1/8/2014; Lot# 121013-101, Exp Date
3/10/2014 |
Class II |
Undeclared wheat |
Custom Ingredients LLC |
Food |
Cheese Pre-mix ME 14-1, in 50 lbs bags intended to be used in the
manufacture of cheese dip |
Lot# 100813-108, Exp Date 4/8/2014; Lot# 112113-102, Exp Date
5/21/2014 |
Class II |
Undeclared wheat |
Custom Ingredients LLC |
Food |
Cheese Pre-mix EF 18-1, in 50 lbs bags intended to be used in the
manufacture of cheese dip |
Lot# 091913-102 |
Class II |
Undeclared wheat |
Custom Ingredients LLC |
Food |
Cheese Pre-mix DRNC, in 50 lbs bags intended to be used in the
manufacture of cheese dip |
Lot# 073113-103/104, Exp Date 1/31/2014; Lot# 091913-105/106,
Exp Date 3/19/2014; Lot# 102813-104/105, Exp Date 4/28/2014; Lot# 121013-103,
Exp Date 6/10/2014 |
Class II |
Undeclared wheat |
Custom Ingredients LLC |
Food |
Monterey Jack Pre-mix HI 10-3, in 50 lbs bags intended to be used
in the manufacture of cheese dip |
Lot# 073113-101/102 |
Class II |
Undeclared wheat |
Custom Ingredients LLC |
Food |
Spinach Pre-mix HG 25-3, in 50 lbs bags intended to be used in the
manufacture of dip |
Lot# 092513-108, Exp Date 12/25/2013; Lot# 010814-103, Exp
Date 4/8/2014 |
Class II |
Undeclared wheat |
Custom Ingredients LLC |
Food |
Cheese Pre-mix JC 6-1, in 50 lbs bags intended to be used in the
manufacture of dip |
Lot# 080113-101/102, Exp Date 2/1/2014; Lot# 092413-104/105,
Exp Date 3/24/2014; Lot# 102513-103, Exp Date 4/25/2014; Lot#
120513-102/103/104/105, Exp Date 6/5/2014; Lot# 010814-104/105, Exp Date
7/8/2014 |
Class II |
Undeclared wheat |
Custom Ingredients LLC |
Food |
Cheese Pre-mix JE 4-2, in 50 lbs bags intended to be used in the
manufacture of cheese dip |
Lot# 082813-103/104/105/106, Exp
Date 11/28/2013; ... More |
Class II |
Undeclared wheat |
Custom Ingredients LLC |
Food |
Natural Cheese Pre-mix DRWC DJ 6-2, in 50 lbs bags intended to be
used in the manufacture of cheese dip |
Lot# 080813-102, Exp Date 2/8/2014; Lot# 090413-102, Exp Date
3/4/2014; Lot# 092413-101, Exp Date 3/24/2014; Lot# 093013-104, Exp Date
3/30/2014; Lot# 120413-103, Exp Date 6/4/2014 |
Class II |
Undeclared wheat |
Custom Ingredients LLC |
Food |
DOS PADRES BRAND; SOUTHWEST QUESO; NET WT. 15.6 oz. (442g);
Distributed by; Cyclone ENTERPRISES; Houston, Texas 77060 UPC: 64258
20110 |
Lot # 03614 A DPSQ |
Class II |
Undeclared Wheat due to a supplier's inadvertent use of a wheat product
instead of whey in preparing the cheese premix for the recalling firm. |
Consolidated Mills, Inc |
Food |
DOS PADRES BRAND; CHIPOTLE QUESO; NET WT. 15.6 oz. (442g);
Distributed by; CYCLONE ENTERPRISES; Houston, Texas 77060 UPC: 64258
20120 |
Lot # 29513 C DPSQ |
Class II |
Undeclared Wheat due to a supplier's inadvertent use of a wheat product
instead of whey in preparing the cheese premix for the recalling firm. |
Consolidated Mills, Inc |
Food |
TRULY TEXAS; CHIPOTLE CON QUESO; Queso With Chipotles; NET WT.; 16
OZ. (453g) and NET WT. 8 OZ. (226g); Distributed by: Double T Gourmet Foods,
Inc.; PO Box 1582 Montgomery, TX 77356; Phone 936-582-6798;
ww.trulytexasfoods.com UPC: 90191 00105 (16 oz.) and UPC: 90191 00129 (8
oz.) |
16 OZ: Lot # 30913 B TTCQ Exp Date 11/5/2014; Lot # 00814 B
TTCQ Exp Date 1/8/2015 8 OZ: Lot # 29413G TTCQ, Exp Date 10/21/2014; 02114A
TTCQ, Exp Date 1/21/2015; 30913 A TTCQ E, Exp Date 11/5/2014 |
Class II |
Undeclared Wheat due to a supplier's inadvertent use of a wheat product
instead of whey in preparing the cheese premix for the recalling firm. |
Consolidated Mills, Inc |
Food |
SILVER STAR; TEX-MEX QUESO; CHIPOTLE QUESO; Medium Dip; NET WT. 16
OZ; (453g); Brought To You By: Silver Star Salsas; Box 50583; Austin, TX
78763 |
Lot # 310afv3A Exp date 11/15/2015; Lot # 022afv4A Exp Date
1/22/2015 |
Class II |
Undeclared Wheat due to a supplier's inadvertent use of a wheat product
instead of whey in preparing the cheese pre-mix for the recalling firm. |
Creative Foodworks, Inc |
Food |
NATIVE TEXAN QUESO; NACHO; Medium; NATIVE TEXAN FOOD Co.; NET WT
16oz 453g 1LB.; NATIVE TEXAN FOOD CO. box 50583, Austin TX 78763
www.NativeTexan1836.com |
Lot # 290afs3A |
Class II |
Undeclared Wheat due to a supplier's inadvertent use of a wheat product
instead of whey in preparing the cheese pre-mix for the recalling firm. |
Creative Foodworks, Inc |
Food |
Central Market HATCH GREEN CHILE QUESO SALSA, NET WT. 16 OZ (1 LB)
454g; DISTRIBUTED BY H-E-B CENTRAL MARKET, AUSTIN, TX 78735 |
Lot # 218afd3A, Exp Date 8/6/2015;
218afd3B,, Exp ... More |
Class II |
Undeclared Wheat due to a supplier's inadvertent use of a wheat product
instead of whey in preparing the cheese pre-mix for the recalling firm. |
Creative Foodworks, Inc |
Food |
Native Texan HATCH GREEN CHILE QUESO SALSA, NET WT. 16 OZ (1 LB)
453g; DISTRIBUTED BY Native Texan Food Co. Box 50583, Austin 78763
www.NATIVETEXAN1836.com |
Lot # 225afd3A, Exp Date 8/13/2015; 225afd3B, Exp Date
8/13/2015; 262afd3A, Exp Date 9/19/2015; 262afd3B,Exp Date 9/19/2015;
290afd3A,Exp Date 10/17/2015; 006afd4A, Exp Date 1/6/2016 |
Class II |
Undeclared Wheat due to a supplier's inadvertent use of a wheat product
instead of whey in preparing the cheese pre-mix for the recalling firm. |
Creative Foodworks, Inc |
Food |
CRAZY JERRY"S DA BIG CHEESE; NET WT. 16 OZ. ( 1 LB.) 454g;
Prepared for Crazy Jerry's Inc. P.O. Box 891 Roswell, GA 30077 |
Lot # 289mf3A |
Class II |
Undeclared Wheat due to a supplier's inadvertent use of a wheat product
instead of whey in preparing the cheese pre-mix for the recalling firm. |
Creative Foodworks, Inc |
Drugs |
VIVITROL (naltrexone for extended-release injectable suspension);
380 mg vial NDC 65757-300-01; RX Only Manufactured and marketed by Alkermes,
Inc., Waltham, MA 02451. |
Batch Number: 412-3732AA; expiration date 07/2016 (NDC#
65757-302-02; Kit Pacaging Lot Number: 2013-021; expiration date 07/2016 (NDC#
65757-300-01. |
Class II |
Customer complaints for failure to deliver the dose. |
Alkermes, Inc. |
Drugs |
Midazolam HCl 2 mg/ml in 0.9% Sodium Chloride in 30 mL PVC Vial,
Rx Only. Pharmakon Pharmaceuticals, Inc., 14450 Getz Rd., Noblesville IN 46060
NDC#: 45183-0234-68. |
Lot #: E21294K3C Exp Date: 6/29/2014 |
Class I |
Incorrect/ Undeclared Excipient: Contains undeclared benzyl alcohol. |
Pharmakon Pharmaceuticals |
Drugs |
Midazolam HCl 1 mg/ml in 0.9% Sodium Chloride in 50 mL and 100 mL
IV bag, Rx Only. Labeled A) 50 mL, Pharmakon Pharmaceuticals, Inc., 14450 Getz
Rd., Noblesville, IN 46060. NDC#: 45183-0989-41. B) 100 mL, Pharmakon
Pharmaceuticals, 14450 Getz Rd., Noblesville, IN 888-660-6715. NDC#:
45183-0796-48. |
A) Lot #: E21294DK1C; Exp Date: 05/22/2014 B) Lot #:
E21294DK3C; Exp Date: 06/08/2014 |
Class I |
Incorrect/ Undeclared Excipient: Contains undeclared benzyl alcohol. |
Pharmakon Pharmaceuticals |
Drugs |
Glycopyrrolate 0.2 mg/ml, 5 mL pre-filled syringe, Rx Only.
Pharmakon Pharmaceuticals, Inc., 14450 Getz Rd., Noblesville, IN 46060, NDC#:
45183-0965-70. |
Lot #: E131210.212 Exp: 07/14/2014 |
Class II |
Incorrect/ Undeclared Excipient: Contains undeclared benzyl alcohol. |
Pharmakon Pharmaceuticals |
Drugs |
Atropine Sulfate 0.4 mg/ml Injection, USP, Total Dosage 0.8 mg per
2 mL, 3 mL pre-filled syringe, Rx Only. Pharmakon Pharmaceuticals, Inc., 14450
Getz Road, Noblesville, IN. NDC: 45183-0105-78. |
Lot #: E0333282R; Exp: 7/13/2014 |
Class I |
Incorrect/ Undeclared Excipient: Contains undeclared benzyl alcohol. |
Pharmakon Pharmaceuticals |
Devices |
Medtronic MiniMed Paradigm Insulin Infusion Pumps, Paradigm
models: MMT-511, MMT-512, MMT-712, MMT-712E, MMT-515, MMT-715, MMT-522,
MMT-522K, MMT-722, MMT-722K, MMT-523, MMT-523K, MMT-723, MMT-723K, MMT-554, and
MMT-754. MiniMed 530G: MMT-551, and MMT-751 Paradigm insulin infusion pumps are
intended for use to deliver basal and bolus insulin to persons with
diabetes. |
Paradigm: MMT-523NAB, MMT-723KNB, MMT-523NAH, MMT-723KNH, MMT
-523NAL, MMT-723KNL, MMT-523NAP, MMT-723KNP, MMT-523NAS, MMT-723KNS, MMT-723NAB,
MMT-723NAH, MMT-723NAL, MMT-723NAP, MMT-723NAS, MMT-523KNB, MMT-523KNH,
MMT-523KNL, MMT-523KNP, MMT-523KNS. MiniMed 530G: MMT-551NAM, MMT-551NAH,
MMT-551NAL, MMT-551NAP, MMT-551NAS, MMT-751NAB, MMT-751NAH, MMT-751NAL,
MMT-751NAP, MMT-751NAS. |
Class II |
Medtronic is recalling the Medtronic MiniMed Paradigm Insulin Infusion Pumps
because they have received reports that users have accidentally programmed the
pump to deliver the maximum bolus amount. |
Medtronic MiniMed Inc. |
Food |
ORGANIC TRADITIONS SPROUTED CHIA SEED POWDER NET WT. 8 oz. and 16
oz., UPC 854260006162, item number AHM616 and UPC 854260005462, item number
AHM546 |
All codes starting with BIO13 and ending with 269 up to and
including 365; All codes starting with BIO14 and ending with 001 up to and
including 156 |
Class I |
HEALTH MATTERS AMERICA INC. of Cheektowaga, New York is voluntarily
recalling Organic Traditions Sprouted Chia Seed Powder, Sprouted Chia & Flax
Seed Powder and Chia Seeds due to possible Salmonella Contamination. |
Health Matters America Inc. |
Food |
ORGANIC TRADITIONS SPROUTED CHIA & FLAX SEED POWDER; NET WT. 8
oz., 16 oz and 50 lbs, UPC 854260006216, item AHM621, UPC 854260005479, item
number AHM547 and item number BLK622 |
For 8 oz. & 16 oz., all codes starting with BIO13 and
ending with 269 up to and including 365 and all codes starting with BIO14 and
ending with 001 up to and including 156. For bulk 50 lb., all lot codes |
Class I |
HEALTH MATTERS AMERICA INC. of Cheektowaga, New York is voluntarily
recalling Organic Traditions Sprouted Chia Seed Powder, Sprouted Chia & Flax
Seed Powder and Chia Seeds due to possible Salmonella contamination |
Health Matters America Inc. |
Food |
ORGANIC SPROUTED DARK SPROUTED CHIA SEED POWDER BULK; NET WT. 50
lb; item number BLK548 |
All lot codes |
Class I |
HEALTH MATTERS AMERICA INC. of Cheektowaga, New York is voluntarily
recalling Organic Traditions Sprouted Chia Seed Powder, Sprouted Chia & Flax
Seed Powder and Chia Seeds due to possible Salmonella contamination |
Health Matters America Inc. |
Food |
ORGANIC TRADITIONS CHIA SEEDS; NET WT. 8 oz., 16 oz. and 50 lb.,
UPC 854260006131, UPC 854260006148, no UPC for 50 lb. |
For 8 oz. & 16 oz., all codes starting with ASCBO13. For
50 lb., all lot codes. |
Class I |
HEALTH MATTERS AMERICA INC. of Cheektowaga, New York is voluntarily
recalling Organic Traditions Sprouted Chia Seed Powder, Sprouted Chia & Flax
Seed Powder and Chia Seeds due to possible Salmonella contamination |
Health Matters America Inc. |
Food |
ORGANIC TRADITIONS ULTIMATE SUPERFOOD TRAILMIX; NET WT. 3.5 oz UPC
854260010701 |
All lots ending in 003-13 to 005-14. |
Class I |
HEALTH MATTERS AMERICA INC. of Cheektowaga, New York is voluntarily
recalling Organic Traditions Sprouted Chia Seed Powder, Sprouted Chia & Flax
Seed Powder and Chia Seeds due to possible Salmonella contamination |
Health Matters America Inc. |
Drugs |
PEDIATRIC CARDIOPLEGIA, 255 mL, Rx Only, Central Admixture
Pharmacy Services, Inc., Livonia, MI 48150 |
Lot # 13-920741-0-1 EXP 21 JUN 2014 |
Class I |
Non Sterility; microbial contamination identified as Aspergillus
species |
Central Admixture Pharmacy Services, Inc. |
Drugs |
del Nido Cardioplegia with Lidocaine 1052.8 ml, Rx Only, Central
Admixture Pharmacy Services, Inc., Livonia, MI 48150 |
Lot# 13-920742-0-1 EXP 21 JUN 2014 and Lot# 13-920452-0-1
through 13-920452-0-30, EXP 21 JUN 2014 |
Class I |
Non Sterility; microbial contamination identified as Aspergillus
species |
Central Admixture Pharmacy Services, Inc. |
Drugs |
adenosine 90 mg in 0.9% sodium chloride/90 mL, Rx Only, Central
Admixture Pharmacy Services, Inc., Livonia, MI 48150 |
Lot# 13-920757-0-1 through Lot# 13-920757-0-5 (5 total doses)
EXP 06 JUL 2014 |
Class I |
Non Sterility; microbial contamination identified as Aspergillus
species |
Central Admixture Pharmacy Services, Inc. |
Drugs |
LOW Potassium Cardioplegia 792 mL, Rx Only, Central Admixture
Pharmacy Services, Inc., Livonia, MI 48150 |
Lot # 13-920739-01 through Lot # 13-920739-04 (4 total doses)
EXP 21 Jun 2014 |
Class I |
Non Sterility; microbial contamination identified as Aspergillus
species
|
Central Admixture Pharmacy Services, Inc. |
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