PlainRecalls
FDA Drug Moderate Class II Terminated

Metoprolol Succinate Extended-Release Tablets, USP, 50 mg, packaged in (a) 100-count bottle, NDC 68001-501-00; (b) 500-count bottle, NDC 68001-501-03. Manufactured by Alkem Laboratories Ltd., India. For BluePoint Laboratories

Reported: February 22, 2023 Initiated: January 11, 2023 #D-0269-2023

Product Description

Metoprolol Succinate Extended-Release Tablets, USP, 50 mg, packaged in (a) 100-count bottle, NDC 68001-501-00; (b) 500-count bottle, NDC 68001-501-03. Manufactured by Alkem Laboratories Ltd., India. For BluePoint Laboratories

Reason for Recall

Failed Dissolution Specifications: This recall is being initiated in support of the recall by the manufacturer which included lots that were packaged for BluePoint Laboratories.

Details

Units Affected
(a) 6670 100-count (b) 2666 500-count bottles
Distribution
Nationwide USA
Location
Columbus, OH

Frequently Asked Questions

What product was recalled?
Metoprolol Succinate Extended-Release Tablets, USP, 50 mg, packaged in (a) 100-count bottle, NDC 68001-501-00; (b) 500-count bottle, NDC 68001-501-03. Manufactured by Alkem Laboratories Ltd., India. For BluePoint Laboratories. Recalled by Amerisource Health Services LLC. Units affected: (a) 6670 100-count (b) 2666 500-count bottles.
Why was this product recalled?
Failed Dissolution Specifications: This recall is being initiated in support of the recall by the manufacturer which included lots that were packaged for BluePoint Laboratories.
Which agency issued this recall?
This recall was issued by the FDA Drug on February 22, 2023. Severity: Moderate. Recall number: D-0269-2023.