Recalls / Class III
Class IIID-0052-2018
Product
Methylphenidate Hydrochloride Tablets USP, 20 mg, 100-count bottles, Rx only, Manufactured by: Watson Laboratories, Inc., Corona, CA 92880 USA, NDC 0591-5884-01.
- Affected lot / code info
- Lot Number # 1156086M, Exp 08/18
Why it was recalled
Failed Dissolution Specifications: Low out of specification results for dissolution.
Recalling firm
- Firm
- Teva Pharmaceuticals USA
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1090 Horsham Rd, N/A, North Wales, Pennsylvania 19454-1505
Distribution
- Quantity
- 58,292 bottles
- Distribution pattern
- Nationwide in the USA and Puerto Rico
Timeline
- Recall initiated
- 2017-10-17
- FDA classified
- 2017-10-26
- Posted by FDA
- 2017-11-01
- Terminated
- 2018-04-12
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0052-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.