Recalls / Class II
Class IID-1443-2012
Product
Meloxicam Tablets, USP, 15 mg, Rx Only, 100 Tablets per Bottle, Manufactured by: Strides Acrolab Ltd., Bangalore-560 076, India, Manufactured for: Apotex Corp., Weston, FL 33326, NDC 60505-3579-1.
- Affected lot / code info
- Lot: 7212558, Exp 12/12.
Why it was recalled
Tablet Thickness: Recall was initiated due to the presence of one slightly oversized tablet in a bottle of the identified lot.
Recalling firm
- Firm
- Apotex Corp.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 2400 N Commerce Pkwy Ste 400, Weston, Florida 33326-3253
Distribution
- Quantity
- 1,749 Bottles
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2012-04-05
- FDA classified
- 2012-08-07
- Posted by FDA
- 2012-08-15
- Terminated
- 2013-09-19
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1443-2012. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.