Reported Aug 14, 2013 · Terminated
Methylphenidate Hydrochloride Extended-Release Capsules (LA), 40 mg, 100 count bottle, Rx only, TEVA PHARMACEUTICALS…
Teva Pharmaceuticals USA, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Teva Pharmaceuticals USA, Inc. · 650 Cathill Rd · Sellersville, PA · 18960-1512
Is this the product you have?
- Methylphenidate Hydrochloride Extended-Release Capsules (LA), 40 mg, 100 count bottle, Rx only, TEVA PHARMACEUTICALS USA, NDC 0093-5348-01
- Lot codes and dates
34010287A34010288A34010289Aexp 4/201434011513A34011514Aand 34011515Aexp 06/14
- Amount recalled
- 7,579 bottles
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Where it was sold
- Nationwide
Why it was recalled
Failed Dissolution Specifications: Product is being recalled due to out of specification dissolution results obtained during routine stability testing.
This product could cause temporary or reversible health problems — stop using it.
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