Wednesday, October 30, 2013

UPDATED!! Alabama Board of Pharmacy: Fines and Discipline Imposed against Manufacturers--And You Thought The FDA Regulated Them....


Manufacturer/Wholesaler/Distributor:

K V PHARMACEUTICAL COMPANY, applicant for mfg/whse/dist
GRANTED upon payment of all required fees and subject to compliance; will not engage in the manufacturing any drugs; comply with terms and conditions of the Consent Decree of Permanent Injunction entered on March 6, 2009 – USA v KV Pharmaceutical Company, et al, in the US District Court for the Eastern District of Missouri, Case No.: 4:09cv-00334; submit to Board by July 15 and January 15 of each year verification of compliance.

NOVARTIS VACCINES & DIAGNOSTICS, INC., #191799
Assessed monetary fine of $500.00.

THER-RX CORPORATION, #192109
Comply with terms and conditions of the Consent Decree of Permanent Injunction entered on March 6, 2009 – USA v KV Pharmaceutical Company, et al, in the US District Court for the Eastern District of Missouri, Case No.: 4:09cv-00334; submit to Board by July 15 and January 15 of each year verification of compliance; assessed monetary fine of $5,000.00.

TRIGEN LABORATORIES, INC., #193875
Assessed monetary fine of $5,000.00; PROBATION 2 years.

UNITED DRUG SUPPLY, #194119
Assessed monetary fine of $500.00.
quoted from here


THE PROCTER AND GAMBLE DISTRIBUTING, LLC., #193786
Assessed monetary fine of $3,000.00.


HAEMONETICS CORPORATION, #193411
Assessed monetary fine of $500.00.

HAEMONETICS CORPORATION, #193412
Assessed monetary fine of $500.00.

NATIONS PHARMACEUTICALS, INC., #193629
Assessed monetary fine of $500.00.

SPECTRUM LABORATORY PRODUCTS, INC., #192564
Assessed monetary fine of $2,000.00; shall obtain pending proper Florida Permits; shall refrain from distribution of legend drugs into Florida until permits have been issued; shall provide copies of new approved Florida Permits to the Board.


COMMONWEALTH HOME HEALTHCARE, #900621
Assessed monetary fine of $2,500.00.

HEALTHCARE & DIAGNOSTIC SOLUTIONS, INC., Permit #193243
All drugs distributed e. g. domestically, importing or exporting, shall contain only pharmaceutical ingredients approved by the FDA, USP, USDA and/or HPUS; Assessed administrative fine of $10,000.00 to be paid within 30 days.





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