Bupropion Hydrochloride Extended-Release Tablets, USP (XL), 300 mg, a) 90-count bottle (NDC 68001-264-05), b) 500-count bottle (NDC 68001-264-03) , Rx only, Manufactured by: Cadila Healthcare Limited, Ahmedabad, India For BluePoint Laboratories
Reported: November 23, 2016 Initiated: October 27, 2016 #D-0137-2017
Product Description
Bupropion Hydrochloride Extended-Release Tablets, USP (XL), 300 mg, a) 90-count bottle (NDC 68001-264-05), b) 500-count bottle (NDC 68001-264-03) , Rx only, Manufactured by: Cadila Healthcare Limited, Ahmedabad, India For BluePoint Laboratories
Reason for Recall
Failed Dissolution Specifications: The firm was notified that there was a dissolution out of specification result on the 6 month stability samples.
Details
- Recalling Firm
- Amerisource Health Services
- Units Affected
- a) 15,409 bottles b) 5,128 bottles
- Distribution
- Nationwide and Puerto Rico
- Location
- Columbus, OH
Frequently Asked Questions
What product was recalled? ▼
Bupropion Hydrochloride Extended-Release Tablets, USP (XL), 300 mg, a) 90-count bottle (NDC 68001-264-05), b) 500-count bottle (NDC 68001-264-03) , Rx only, Manufactured by: Cadila Healthcare Limited, Ahmedabad, India For BluePoint Laboratories. Recalled by Amerisource Health Services. Units affected: a) 15,409 bottles b) 5,128 bottles.
Why was this product recalled? ▼
Failed Dissolution Specifications: The firm was notified that there was a dissolution out of specification result on the 6 month stability samples.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on November 23, 2016. Severity: Low. Recall number: D-0137-2017.
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