Reported Apr 11, 2018 · Terminated
buPROPion HCl Extended-Release Tablets, USP (SR), 100 mg, 60 count bottles, Rx Only, Manufactured for: Cipla USA Inc.…
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), 100 mg, 60 count 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 --- NDC 69097-877-03
- Lot codes and dates
- Lot# I1606579 and Lot#
- I1606580 Exp
05/2018Lot# I1612114 and Lot#
- I1612115 Exp11/2018
- 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.
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 InvaGen Pharmaceuticals, Inc. 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.