Why it was recalled
Subpotent Drug
Product description
Vancomycin Hydrochloride Capsules, USP, 250 mg, 2 x 10 count blister pack, Rx Only, Manufactured for Watson Pharma Inc., Parsippany, NJ 07054, by Patheon Pharmaceuticals Inc., Cincinnati, OH. NDC 0591-3561-15
Lot numbers, UPCs & expiration codes
Lot #: 3109554, Exp 3/31/2015; Lot #: 3111457, Exp 3/31/2015; Lot #: 3112973, Exp 7/31/2015; Lot #: 3114262, Exp 6/30/2015; Lot #: 3114076, Exp 12/31/2015; Lot #: 3115889, Exp 12/31/2015; Lot #: 3116033, Exp 12/31/2015.
Where it was sold
Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0406-2015
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Feb 12, 2015
- FDA report date
- Mar 11, 2015
- Quantity
- 29,405 cartons
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Actavis Inc
Original FDA data
Every field from FDA enforcement report D-0406-2015, exactly as published.
Show all FDA fields
- City
- Parsippany
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 70555
- Address
- 400 Interpace Pkwy
- Code information
- Lot #: 3109554, Exp 3/31/2015; Lot #: 3111457, Exp 3/31/2015; Lot #: 3112973, Exp 7/31/2015; Lot #: 3114262, Exp 6/30/2015; Lot #: 3114076, Exp 12/31/2015; Lot #: 3115889, Exp 12/31/2015; Lot #: 3116033, Exp 12/31/2015.
- Postal code
- 07054-1120
- Report date
- Mar 11, 2015
- Product type
- Drugs
- Recall number
- D-0406-2015
- Classification
- Class II
- Recalling firm
- Actavis Inc
- Product quantity
- 29,405 cartons
- Termination date
- Dec 4, 2015
- Reason for recall
- Subpotent Drug
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Vancomycin Hydrochloride Capsules, USP, 250 mg, 2 x 10 count blister pack, Rx Only, Manufactured for Watson Pharma Inc., Parsippany, NJ 07054, by Patheon Pharmaceuticals Inc., Cincinnati, OH. NDC 0591-3561-15
- Distribution pattern
- Nationwide
- Recall initiation date
- Feb 12, 2015
- Initial firm notification
- Letter
- Center classification date
- Mar 3, 2015