Methylphenidate Hydrochloride Extended-Release Capsules (LA), 40 mg, 100 count bottle, Rx only, TEVA PHARMACEUTICALS USA, NDC 0093-5348-01

FDA recall notice · announced August 14, 2013 · Teva Pharmaceuticals

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The product

Reason for recall

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

Notes

Distribution: Nationwide
Lot/code information: 34010287A, 34010288A, 34010289A, exp 4/2014; 34011513A, 34011514A, and 34011515A, exp 06/14.
Quantity: 7,579 bottles
Status: Terminated
Products in this recall event:
- Methylphenidate Hydrochloride Extended-Release Capsules (LA), 20 mg, 100 count bottle, Rx only, TEVA PHARMACEUTICALS USA, NDC 0093-5346-01 (D-847-2013)
- Methylphenidate Hydrochloride Extended-Release Capsules (LA), 30 mg, 100 count bottle, Rx only, TEVA PHARMACEUTICALS USA, NDC 0093-5347-01 (D-848-2013)
- Methylphenidate Hydrochloride Extended-Release Capsules (LA), 40 mg, 100 count bottle, Rx only, TEVA PHARMACEUTICALS USA, NDC 0093-5348-01 (D-849-2013)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.