BuPROPion Hydrochloride Extended-Release Tablets (XL), 300 mg, 30-count tablets per bottle, Rx only, Distributed by: Actavis South Atlantic, LLC, Sunrise, FL 33325; Packaged by: American Health Packaging, Columbus, OH 43217, NDC 67767-142-30, UPC 3 67767-142-30 6.
Reported: August 14, 2013 Initiated: July 31, 2013 #D-855-2013
Product Description
BuPROPion Hydrochloride Extended-Release Tablets (XL), 300 mg, 30-count tablets per bottle, Rx only, Distributed by: Actavis South Atlantic, LLC, Sunrise, FL 33325; Packaged by: American Health Packaging, Columbus, OH 43217, NDC 67767-142-30, UPC 3 67767-142-30 6.
Reason for Recall
Failed Dissolution Specifications: Dissolution test results at 8 hour time-point were above approved specification limits.
Details
- Recalling Firm
- Actavis Inc
- Units Affected
- 15,132 bottles
- Distribution
- Nationwide and Puerto Rico
- Location
- Parsippany, NJ
Frequently Asked Questions
What product was recalled? ▼
BuPROPion Hydrochloride Extended-Release Tablets (XL), 300 mg, 30-count tablets per bottle, Rx only, Distributed by: Actavis South Atlantic, LLC, Sunrise, FL 33325; Packaged by: American Health Packaging, Columbus, OH 43217, NDC 67767-142-30, UPC 3 67767-142-30 6.. Recalled by Actavis Inc. Units affected: 15,132 bottles.
Why was this product recalled? ▼
Failed Dissolution Specifications: Dissolution test results at 8 hour time-point were above approved specification limits.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on August 14, 2013. Severity: Low. Recall number: D-855-2013.
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