Metoprolol Succinate ER Tablets Recalled for Failed Dissolution Specifications
Amerisource Health Services is recalling Metoprolol Succinate Extended-Release Tablets due to failed dissolution specifications that may prevent proper drug release.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall for a manufacturing defect (failed dissolution specifications) in a cardiovascular medication. While no illnesses or injuries are reported, this poses a risk of inadequate drug efficacy for patients dependent on metoprolol succinate for heart conditions.
Plain-English summary
Amerisource Health Services LLC is recalling Metoprolol Succinate Extended-Release Tablets, USP, 50 mg due to failed dissolution specifications. The affected lots were originally packaged for BluePoint Laboratories and include 100-count bottles (NDC 68001-501-00) and 500-count bottles (NDC 68001-501-03).
Failed dissolution specifications indicate that the tablets may not dissolve properly in the digestive system, which could prevent adequate drug release and absorption. Metoprolol succinate is a beta-blocker used to treat heart conditions. Inadequate medication delivery could compromise the drug's therapeutic effectiveness.
The recalled product was distributed nationwide in the United States. The specific affected lot numbers are 21143211 (expiration 03/31/2023) and 21143185 and 21143193 (expiration 02/28/2023). No adverse events or illnesses have been reported in connection with this recall.
The recalled product
- Product
- METOPROLOL SUCCINATE (METOPROLOL SUCCINATE ER TABLETS)
- Brand
- METOPROLOL SUCCINATE
- Manufacturer
- Amerisource Health Services LLC
- Category
- Drug — Cardiovascular
- Hazard
- dissolution-failure
- medication-efficacy
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- Lots: (a) 21143211
- EXP 03/31/2023
- (b) 21143185
- 21143193
- EXP 02/28/2023
UPCs (1)
- 0368001500005
Distribution
Distributed nationwide across the United States.
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