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Pharmaceuticals / Quality / Postmarket Safety / Commercial Operations

California Compounder Recalls Meds Following Quality, Labeling Concerns

April 4, 2016

A California compounding operation is recalling roughly 100 lots of various medications after an FDA inspection raised concerns about quality assurance and labeling accuracy.

The recall affects no more than 100 prescriptions filled with various medications, most of which went to patients and veterinarians in California. The drugs were compounded by Reliable Drug Pharmacy of San Francisco between Sept. 24, 2015, and March 24, according to Natalia Mazina, a managing partner at a law firm representing the pharmacy. FDA announced the recall last week.

Mazina declined to go into details about the findings by an FDA inspector that prompted the recall. She did say that the pharmacy does not engage in sterile compounding, so consumers should be in no danger.