InvaGen Pharmaceuticals, Inc. recalls buPROPion HCl Extended-Release Tablets, USP (SR), 150 mg ,a) 60 count (NDC 69097-878-03) and b) 100 count (NDC 69097-87…
- Recall date
- March 15, 2018
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- D-0619-2018
- FDA classification
- Class III
- Brand / firm
- InvaGen Pharmaceuticals, Inc.
- Sold / distributed
- Nationwide
Why it was recalled
Failed Dissolution Specifications; during stability testing
Class III means the product violates regulations but is not likely to cause harm.
What was recalled
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 for: Cipla USA Inc. 1560 Sawgrass Corporate Parkway Suite 130 Sunrise, FL 33323, Manufactured by: InvaGen Pharmaceuticals, Inc. (a subsidiary of Cipla Ltd.) Hauppauge, NY 11788
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