PlainRecalls
FDA Drug Low Class III Terminated

Methylphenidate Hydrochloride Tablets USP, 20 mg, 100-count bottles, Rx only, Manufactured by: Watson Laboratories, Inc., Corona, CA 92880 USA, NDC 0591-5884-01.

Reported: November 1, 2017 Initiated: October 17, 2017 #D-0052-2018

Product Description

Methylphenidate Hydrochloride Tablets USP, 20 mg, 100-count bottles, Rx only, Manufactured by: Watson Laboratories, Inc., Corona, CA 92880 USA, NDC 0591-5884-01.

Reason for Recall

Failed Dissolution Specifications: Low out of specification results for dissolution.

Details

Recalling Firm
Teva Pharmaceuticals USA
Units Affected
58,292 bottles
Distribution
Nationwide in the USA and Puerto Rico
Location
North Wales, PA

Frequently Asked Questions

What product was recalled?
Methylphenidate Hydrochloride Tablets USP, 20 mg, 100-count bottles, Rx only, Manufactured by: Watson Laboratories, Inc., Corona, CA 92880 USA, NDC 0591-5884-01.. Recalled by Teva Pharmaceuticals USA. Units affected: 58,292 bottles.
Why was this product recalled?
Failed Dissolution Specifications: Low out of specification results for dissolution.
Which agency issued this recall?
This recall was issued by the FDA Drug on November 1, 2017. Severity: Low. Recall number: D-0052-2018.