Class II · Moderate risk
Ascend Laboratories
Failed Dissolution Specifications
Wockhardt Metoprolol Succinate
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Failed Dissolution Specifications: Product was out of specification (OOS) at the 12 month long term stability testing point.
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.
What was recalled
Wockhardt Metoprolol Succinate, Extended-Release Tablets USP, 50 mg, a)100-count HDPE bottle (NDC 64679-735-02), b) 4000-count pack (64679-735-08), Manufactured by: Wockhardt Limited, Mumbai, India Distributed by Wockhardt USA LLC. 20 Waterview Blvd. Parsippany, NJ 07054 USA .
Affected NDCs
64679-0735-02
64679-0735-08
Compare with the code on your package — it is the most precise check available.
Drug: Metoprolol Category: Blood Pressure Medication
- Recalling firm
- Wockhardt Usa Inc.
- NDC code
- 64679-735-02
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0304-2015 · FDA notice
Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Metoprolol recalls
See all
Class II · Moderate risk
Metoprolol Succinate Extended-Release Tablets
Failed Dissolution Specifications
Class II · Moderate risk
Metoprolol Succinate Extended-Release Tablets
Failed Dissolution Specifications
Class II · Moderate risk
Metoprolol Succinate Extended-Release Tablets
Failed Dissolution Specifications
Class II · Moderate risk
Metoprolol Succinate Extended-Release Tablets
Failed Dissolution Specifications
Other recalls by Wockhardt Usa Inc.
All 2014 recalls
Class III · Low risk
Enalapril Maleate Tablets USP
Failed Impurities/Degradation Specifications
Class III · Low risk
Enalapril Maleate Tablets USP
Failed Impurities/Degradation Specifications
Class III · Low risk
Enalapril Maleate tablets
Failed Impurities/Degradation Specifications: 5mg strength being recalled for out of specification results for related compound.
Class II · Moderate risk
Lisinopril Tablets USP
CGMP Deviations: An FDA inspection identified inadequate investigations of past market complaints.
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