buPROPion Hydrochloride Extended Release Tablets, USP 100 mg, 100 count carton, 10 blister cards of 10 individually blistered and labeled tablets, Rx only, Actavis South Atlantic LLC, Packaged and Distributed by: American Health Packaging, Columbus, OH --- NDC 68084-470-01
Reported: August 21, 2013 Initiated: February 4, 2013 #D-892-2013
Product Description
buPROPion Hydrochloride Extended Release Tablets, USP 100 mg, 100 count carton, 10 blister cards of 10 individually blistered and labeled tablets, Rx only, Actavis South Atlantic LLC, Packaged and Distributed by: American Health Packaging, Columbus, OH --- NDC 68084-470-01
Reason for Recall
Failed Stability Specifications; out of specification results at the 9 month stability time point for color, dissolution and related compounds.
Details
- Recalling Firm
- American Health Packaging
- Units Affected
- 389 cartons
- Distribution
- Nationwide
- Location
- Columbus, OH
Frequently Asked Questions
What product was recalled? ▼
buPROPion Hydrochloride Extended Release Tablets, USP 100 mg, 100 count carton, 10 blister cards of 10 individually blistered and labeled tablets, Rx only, Actavis South Atlantic LLC, Packaged and Distributed by: American Health Packaging, Columbus, OH --- NDC 68084-470-01. Recalled by American Health Packaging. Units affected: 389 cartons.
Why was this product recalled? ▼
Failed Stability Specifications; out of specification results at the 9 month stability time point for color, dissolution and related compounds.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on August 21, 2013. Severity: Low. Recall number: D-892-2013.
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