buPROPion HCl Extended-Release Tablets, USP (SR), 100 mg, 60 count 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 --- NDC 69097-877-03
Reported: April 11, 2018 Initiated: March 15, 2018 #D-0618-2018
Product Description
buPROPion HCl Extended-Release Tablets, USP (SR), 100 mg, 60 count 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 --- NDC 69097-877-03
Reason for Recall
Failed Dissolution Specifications; during stability testing
Details
- Recalling Firm
- InvaGen Pharmaceuticals, Inc.
- Units Affected
- N/A
- Distribution
- Nationwide
- Location
- Hauppauge, NY
Frequently Asked Questions
What product was recalled? ▼
buPROPion HCl Extended-Release Tablets, USP (SR), 100 mg, 60 count 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 --- NDC 69097-877-03. Recalled by InvaGen Pharmaceuticals, Inc.. Units affected: N/A.
Why was this product recalled? ▼
Failed Dissolution Specifications; during stability testing
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on April 11, 2018. Severity: Low. Recall number: D-0618-2018.
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