buPROPion Hydrochloride Extended-Release Tablets, USP (XL), 300mg, 500-count bottle, Rx only, Manufactured by: Cadila Healthcare Ltd., Ahmedabad, India For BluePoint Laboratories, NDC 68001-264-03
Reported: September 21, 2016 Initiated: August 4, 2016 #D-1501-2016
Product Description
buPROPion Hydrochloride Extended-Release Tablets, USP (XL), 300mg, 500-count bottle, Rx only, Manufactured by: Cadila Healthcare Ltd., Ahmedabad, India For BluePoint Laboratories, NDC 68001-264-03
Reason for Recall
Failed dissolution specifications - the out of specification result for dissolution was identified during 3 month stability testing.
Details
- Recalling Firm
- Amerisource Health Services
- Units Affected
- 2626 bottles
- Distribution
- Nationwide and Puerto Rico
- Location
- Columbus, OH
Frequently Asked Questions
What product was recalled? ▼
buPROPion Hydrochloride Extended-Release Tablets, USP (XL), 300mg, 500-count bottle, Rx only, Manufactured by: Cadila Healthcare Ltd., Ahmedabad, India For BluePoint Laboratories, NDC 68001-264-03. Recalled by Amerisource Health Services. Units affected: 2626 bottles.
Why was this product recalled? ▼
Failed dissolution specifications - the out of specification result for dissolution was identified during 3 month stability testing.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on September 21, 2016. Severity: Low. Recall number: D-1501-2016.
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