PlainRecalls
FDA Drug Moderate Class II Terminated

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

Reported: February 19, 2020 Initiated: January 27, 2020 #D-0837-2020

Product Description

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.

Details

Recalling Firm
Teva Pharmaceuticals USA
Units Affected
17,436 bottles
Distribution
USA Nationwide
Location
Parsippany, NJ

Frequently Asked Questions

What product was recalled?
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. Recalled by Teva Pharmaceuticals USA. Units affected: 17,436 bottles.
Why was this product recalled?
CGMP deviations: Product bottle may be absent of desiccant.
Which agency issued this recall?
This recall was issued by the FDA Drug on February 19, 2020. Severity: Moderate. Recall number: D-0837-2020.