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

FDA recall notice · announced February 22, 2023 · Amerisource Health Services

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The product

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.

Notes

Distribution: Nationwide USA
Lot/code information: Lots: (a) 21143211, EXP 03/31/2023; (b) 21143185, 21143193, EXP 02/28/2023
Quantity: (a) 6670 100-count (b) 2666 500-count bottles
Status: Terminated
Products in this recall event:
- 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. F (D-0269-2023)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.