Recalls / Class II
Class IID-1386-2014
Product
Vancomycin Hydrochloride Capsules, USP, 250 mg. 20 Capsules on 2 x 10 Capsule Blister Cards, Rx Only. Mfd. for: Watson Pharma Inc., Parsippany, NJ 07054 USA. Mfd. by: Patheon Pharmaceuticals Inc., Cincinnati, OH 45237 USA. NDC 0591-3561-15.
- Affected lot / code info
- Lot #: 3100135, Expiry: 05/2014
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
- 6913 packages
- Distribution pattern
- U.S. Nationwide
Timeline
- Recall initiated
- 2014-05-16
- FDA classified
- 2014-06-17
- Posted by FDA
- 2014-06-25
- Terminated
- 2015-02-23
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1386-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.