D-0396-2015 Class II Terminated
FDA drug recall D-0396-2015 was initiated by Actavis Inc on Feb 12, 2015 and is designated Class II. Reason for recall: Subpotent Drug The recall status is terminated (terminated Dec 4, 2015). Affected quantity: 51,472 cartons.
Recall details
- Product Type
- Drugs
- Report Date
- Mar 11, 2015
- Initiation Date
- Feb 12, 2015
- Termination Date
- Dec 4, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 51,472 cartons
Product description
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
Reason for recall
Subpotent Drug
Distribution pattern
Nationwide
Code information
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.
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0396-2015
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026