FDA recall D-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

Reason for recall

CGMP deviations: Product bottle may be absent of desiccant.

Distribution

USA Nationwide

Key facts

Status

Terminated

Initiation date

2020-01-27

Report date

2020-02-19

Termination date

2020-11-03

Voluntary/Mandated

Voluntary: Firm initiated

Location

Parsippany, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0837-2020