FDA-Drug2013-08-14Class II

Methylphenidate Hydrochloride Extended-Release Capsules (LA), 20 mg, 100 count bottle, Rx only, TEVA PHARMACEUTICALS USA, NDC 0093-5346-01

Teva Pharmaceuticals USA, Inc.
Hazard

Failed Dissolution Specifications: Product is being recalled due to out of specification dissolution results obtained during routine stability testing.

Sold states
Nationwide
Affected count
16,293 bottles
Manufactured in
650 Cathill Rd, N/A, Sellersville, PA, United States
Products
Methylphenidate Hydrochloride Extended-Release Capsules (LA), 20 mg, 100 count bottle, Rx only, TEVA PHARMACEUTICALS USA, NDC 0093-5346-01

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-847-2013

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