Reported May 7, 2014 · Terminated
Venlafaxine Hydrochloride Extended-Release Tablets, 37.5 mg, packaged in a) 30-count bottles (NDC 41616-760-83, 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, 37.5 mg, packaged in a) 30-count bottles (NDC 41616-760-83, UPC 3 41616 76083 5); and b) 90-count bottles (NDC 41616-760-81, UPC 3 41616 76081 1), 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
Lot #: a) JKL4344AExp 07/14JKL5460AExp 10/14JKL5458AExp 11/14b) JKL4344BExp 07/14JKL5460BExp 10/14JKL5458BExp 11/14
- Amount recalled
- 91,777 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.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Caraco Pharmaceutical Laboratories, Ltd. recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.