Reported Apr 11, 2018 · Terminated
buPROPion HCl Extended-Release Tablets, USP (SR), 150 mg ,a) 60 count (NDC 69097-878-03) and b) 100 count (NDC…
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 HCl Extended-Release Tablets, USP (SR), 150 mg ,a) 60 count (NDC 69097-878-03) and b) 100 count (NDC 69097-878-07) bottles, Rx Only
- Manufactured forCipla USA Inc. 1560 Sawgrass Corporate Parkway Suite 130 Sunrise, FL 33323
- Manufactured byInvaGen Pharmaceuticals, Inc. (a subsidiary of Cipla Ltd.) Hauppauge, NY 11788
- Lot codes and dates
- a) Lot I1606609 and Lot I1606610 Exp. Date 05/2018; Lot I1610639 Exp. Date 09/2018 b) Lot #I1606610 Exp Date 05/2018; Lot I1607847 and Lot I1607845 Exp Date 06/2018; Lot I1610639 Exp Date 09/2018
- Amount recalled
- N/A
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
Failed Dissolution Specifications; during stability testing
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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