Recalls / Class II
Class IID-0837-2020
Product
Methylphenidate hydrochloride Extended-Release ablets USP (CII), 27 mg, 100-count bottle, Rx only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 62037-734-01
- Brand name
- Methylphenidate Hydrochloride
- Generic name
- Methylphenidate Hydrochloride
- Active ingredient
- Methylphenidate Hydrochloride
- Route
- Oral
- NDCs
- 62037-725, 62037-734, 62037-726, 62037-727
- FDA application
- ANDA076772
- Affected lot / code info
- Lot # 1332799A, Exp 11/2020
Why it was recalled
CGMP deviations: Product bottle may be absent of desiccant.
Recalling firm
- Firm
- Teva Pharmaceuticals USA
- Manufacturer
- Actavis Pharma, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 400 Interpace Pkwy, Parsippany, New Jersey 07054-1120
Distribution
- Quantity
- 17,436 bottles
- Distribution pattern
- USA Nationwide
Timeline
- Recall initiated
- 2020-01-27
- FDA classified
- 2020-02-10
- Posted by FDA
- 2020-02-19
- Terminated
- 2020-11-03
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0837-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.