September 9th, 2014

Massive Antibiotic Recall

Massive Antibiotic Recall
August 22, 2014
Caraco Pharmaceuticals, a subsidiary of Sun Pharmaceutical, is in the process of recalling more than 450,000 units of an antibiotic. The active ingredient in cephalexin was not produced in according to the U.S. Food and Drug Administration’s good manufacturing practices.

More than 340,000 units of the 500 mg dose and more than 113,000 units of the 250 mg dose are being recalled.

This latest recall started in June, according to the report.

India’s drug manufacturing industry has seen a number of recalls over the past few months due to quality issues. Ranbaxy recalled approximately 30,000 packs of allergy medications in February. Glenmark recalled nearly 3,000 bottles of an ulcer drug in March. Wockhardt recalled more than 100,000 bottles of a hypertension medication in April.

Reuters reported in May that over the next three years India plans to invest more than $500 million, increase the number of drug inspectors from 1,000 to 1,500, and increasing the number of state regulatory departments from 800 to 3,000.

Where are the good old days with U.S. manufactured drugs with all the US Pharmacopea protections for the patients???? 

 

References:

1. Sun conducts massive recall due to poor quality of APIs. FDANews. 2014 Aug 22.

2. Reuters staff. India to double drug inspectors to boost oversight. Pharmacy Learning Network. 2014 May 21.

3. Reuters staff. Ranbaxy recalls nearly 30,000 packs of allergy-relief drug in U.S. Pharmacy Learning Network. 2014 May 5.

4. Reuters staff. India's Glenmark pulls 2,900 bottles of ulcer drug in U.S. Pharmacy Learning Network. 2014 Apr 22.

5. Reuters staff. Wockhardt recalls over 109,000 bottles of hypertension drug in U.S. Pharmacy Learning Network. 2014 May 15.

PLN Topics:
Infectious Diseases
Medication Errors
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