Recalls / Class II
Class IID-0233-2015
Product
Vancomycin Hydrochloride Capsule, USP, 250 mg, 20 count blister pack, Rx Only, Mfd. for: Watson Pharma. Inc. Parsippany, NJ 07054 USA, Mfd. by: Patheon Pharmaceuticals Inc. Cincinnati, OH 45237 USA ---- NDC 0591-3561-15 UPC 3-3-0591356115-1
- Affected lot / code info
- 3101178, exp Aug 2014, 3104318, exp Aug 2014, 3104319, exp Oct 2014, 3104889, exp Oct 2014, 3104891, exp Oct 2014, 3104893, exp Oct 2014, and 3106651, exp Dec 2014
Why it was recalled
Subpotent Drug
Recalling firm
- Firm
- Actavis Inc
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 400 Interpace Pkwy, N/A, Parsippany, New Jersey 07054-1120
Distribution
- Quantity
- 46,676 cartons
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2014-08-25
- FDA classified
- 2014-10-30
- Posted by FDA
- 2014-11-05
- Terminated
- 2018-03-21
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0233-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.