BuPROPion Hydrochloride Extended-Release Tablet (XL) 150mg, Rx only, a) 30 count bottle(NDC 0591-3331-30), b) 90 count bottle (NDC 0591-3331-19), c) 500 count bottle (NDC 0591-3331-05), Manufactactred By: Watson Laboratories, Inc. Corona, CA 92880
Reported: February 5, 2014 Initiated: November 15, 2013 #D-1043-2014
Product Description
BuPROPion Hydrochloride Extended-Release Tablet (XL) 150mg, Rx only, a) 30 count bottle(NDC 0591-3331-30), b) 90 count bottle (NDC 0591-3331-19), c) 500 count bottle (NDC 0591-3331-05), Manufactactred By: Watson Laboratories, Inc. Corona, CA 92880
Reason for Recall
Failed Dissolution Specifications: Failed stability testing for dissolution test at 18 months.
Details
- Recalling Firm
- Actavis Inc
- Units Affected
- 139,944 bottles
- Distribution
- Nationwide and Puerto Rico
- Location
- Parsippany, NJ
Frequently Asked Questions
What product was recalled? ▼
BuPROPion Hydrochloride Extended-Release Tablet (XL) 150mg, Rx only, a) 30 count bottle(NDC 0591-3331-30), b) 90 count bottle (NDC 0591-3331-19), c) 500 count bottle (NDC 0591-3331-05), Manufactactred By: Watson Laboratories, Inc. Corona, CA 92880. Recalled by Actavis Inc. Units affected: 139,944 bottles.
Why was this product recalled? ▼
Failed Dissolution Specifications: Failed stability testing for dissolution test at 18 months.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on February 5, 2014. Severity: Low. Recall number: D-1043-2014.
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