Reported May 7, 2014 · Terminated
Venlafaxine Hydrochloride Extended-Release Tablets, 150 mg, packaged in a) 30-count bottles (NDC 41616-758-83, UPC 3…
Caraco Pharmaceutical Laboratories, Ltd.
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: Caraco Pharmaceutical Laboratories, Ltd. · 1150 Elijah McCoy Dr · Detroit, MI · 48202-3344
Is this the product you have?
- Venlafaxine Hydrochloride Extended-Release Tablets, 150 mg, packaged in a) 30-count bottles (NDC 41616-758-83, UPC 3 41616 75883 2); and b) 90-count bottles (NDC 41616-758-81, UPC 3 41616 75881 8), Rx only
- Distributed byCaraco Pharmaceutical Laboratories, Ltd., 1150 Elijah McCoy Drive, Detroit, MI 48202
- Manufactured atSun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol-389 350, Gujarat, India
- Lot codes and dates
9 of 9 products
Products covered by this recall # Product as published 1 JKL3354A, Exp 04/14 2 JKL5444A, Exp 08/14 3 JKL5457B, JKL5445A, Exp 09/14 4 JKL5840A, Exp 10/14 5 JKL6588A, Exp 11/14 6 JKL3354B, Exp 04/14 7 JKL5444B, Exp 08/14 8 JKL5457C, JKL5445B, Exp 09/14 9 JKL5840B, Exp 10/14. - Amount recalled
- 160,105 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
- PR
Why it was recalled
Failed Dissolution Specifications: Stability results found the product did not meet the drug release dissolution specifications.
This product could cause temporary or reversible health problems — stop using it.
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