D-0836-2020 Class II Terminated
FDA drug recall D-0836-2020 was initiated by Teva Pharmaceuticals USA on January 27, 2020 and is designated Class II. Reason for recall: CGMP deviations: Product bottle may be absent of desiccant. The recall status is terminated (terminated November 3, 2020).
Recall Details
- Product Type
- Drugs
- Report Date
- February 19, 2020
- Initiation Date
- January 27, 2020
- Termination Date
- November 3, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
Product Description
Methylphenidate hydrochloride Extended-Release ablets USP (CII), 18 mg, 100-count bottle, Rx only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 62037-725-01
Reason for Recall
CGMP deviations: Product bottle may be absent of desiccant.
Distribution Pattern
USA Nationwide
Code Information
Lot #: 1332796 A, Exp 11/2020