FDA-Drug2017-11-01Class III

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

Teva Pharmaceuticals USA
Hazard

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

Sold states
Nationwide in the USA and Puerto Rico
Affected count
58,292 bottles
Manufactured in
1090 Horsham Rd, N/A, North Wales, PA, United States
Products
Methylphenidate Hydrochloride Tablets USP, 20 mg, 100-count bottles, Rx only, Manufactured by: Watson Laboratories, Inc., Corona, CA 92880 USA, NDC 0591-5884-01.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0052-2018

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