March 20th, 2015

STATIN DRUG RECALL

Statin Recall

March 19, 2015

Statin Recall

Think we’ve seen the end of drug recalls due to quality issues associated with Indian drug manufacturing?  Think again.  A major recall has resulted in more than 54,000 bottles of statins being recalled due to quality issues.

Simvastatin (Zocor), manufactured by in Goa, India, are distributed by Micro Labs USA, located in Princeton, New Jersey.

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Three dosages are being recalled: 13,464 bottles of the 80 mg, 13,488 of the 40 mg, and 27,144 of the 20 mg, according to a report in The Economic Times of India.

The lots being recalled are:

Related: Nationwide Voluntary Recall of Two Antibiotics
Lot Number                                                 Expiration Date

STCG005                                                         January 2015

STCG011                                                          March 2015

STCG012                                                          February 2015

STDG010                                                         March 2015

STEG004                                                         February 2015

STEG006                                                        March 2015

They company launched the Class III recall in December.

Drug manufacturing in India has been plagued with a number of violations and recalls in the recent past.  What's going on?

References:

1. U.S. Food and Drug Administration. Enforcement Report – Week of March 18, 2015. www.accessdata.fda.gov. Accessed March 19, 2015.

2. Micro Labs recalls 54,096 bottles of cholesterol drug in US. The Economic Times. www.indiatimes.com. 2015 Mar 19.