Recalls / Class II
Class IID-0232-2015
Product
Vancomycin Hydrochloride Capsule, USP, 125 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 0591-3560-15 UPC Code 3-0591356015-4
- Affected lot / code info
- 3103681, exp Aug 2014, 3104886, exp Oct 2014, 3105836, exp Dec 2014, and 3106650, 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
- 26,663 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-0232-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.