Recalls / Class II
Class IID-0396-2015
Product
Vancomycin Hydrochloride Capsules, USP, 125 mg, 2 x 10 count blister pack, Rx Only, Manufactured for Watson Pharma Inc., Parsippany, NJ 07054, by Patheon Pharmaceuticals Inc., Cincinnati, OH. NDC 0591-3560-15
- Affected lot / code info
- Lot #: 310935 Exp 3/31/2015; Lot #: 3109552 Exp 3/31/2015; Lot #: 3110204, Exp 3/31/2015; Lot #: 3112972, Exp 7/31/2015; Lot #: 3114073, Exp 8/31/2015; Lot #: 3115756, Exp 10/31/2015, Lot #: 3115888, Exp 10/31/2015; Lot #: 3118059, Exp 11/30/2015.
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
- 51,472 cartons
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2015-02-12
- FDA classified
- 2015-03-03
- Posted by FDA
- 2015-03-11
- Terminated
- 2015-12-04
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0396-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.