Reported Sep 26, 2018 · Terminated
Bupropion Hydrochloride ER Tablets, USP 150 mg, packaged in a) 90-count bottle (NDC 69097-875-05), Manufactured for:…
InvaGen Pharmaceuticals, Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.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: InvaGen Pharmaceuticals, Inc. · 7 Oser Ave · Hauppauge, NY · 11788-3811
Is this the product you have?
- Bupropion Hydrochloride ER Tablets, USP 150 mg, packaged in a) 90-count bottle (NDC 69097-875-05)
- Manufactured forCipla USA Inc., 1560 Sawgrass Corporate Parkway, Suite 130 Sunrise, FL 33323 b) 90-count bottle (NDC 68001-322-05), For BluePoint Laboratories, Rx only
- Manufactured byInvaGen Pharmaceuticals, Inc. (a subsidiary of Cipla Ltd.) Hauppauge, NY 11788
- Lot codes and dates
Lot #: a) 16121301612131Exp 11/181709986Exp 8/191711549Exp 10/19b) 1701171170117417011751701176Exp 12/18170513117051321705133Exp 4/1917099861709985Exp 8/1917110257Exp 9/19171280918010411801051Exp 12/191802283Exp 1/20
- Amount recalled
- 26,496 bottles
Where it was sold
- Nationwide
Why it was recalled
Failed impurities/ degradation specifications: Out-of-specification results were observed in the meta-chlorobenzoic acid impurity in batches 18 months or older from date of manufacture in the 90 count bottle size.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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