Ascend Laboratories
Failed Dissolution Specifications
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
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.
Cause type: Dissolution failure
The tablet or capsule did not dissolve within specification. Dissolution controls how much drug the body absorbs; a failure can change the effective dose. All dissolution failure recalls.
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
Compare with the code on your package — it is the most precise check available.
Drug: Metoprolol Category: Blood Pressure Medication
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Metoprolol Succinate Metoprolol Succinate ER Tablets NDC 68001-0501 |
METOPROLOL SUCCINATE 50 mg/1 | Tablet, Film Coated, Extended Release Oral |
BluePoint Laboratories | Rx |
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Failed Dissolution Specifications
Failed Dissolution Specifications
Failed Dissolution Specifications
Failed Dissolution Specifications
Failed Dissolution Specifications
Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
Failed tablet specifications.
Defective container: card seal defects (weak/non-existent seals), leading to the tablets falling out of their cavities.
Free recall alerts
Tell us what you take. When FDA posts a recall announcement or classifies a recall for one of your medications, we email you in plain English, with what to check. No account needed.