Metoprolol Succinate Extended-Release Tablets, USP, 50 mg, 30-count bottle, Rx only, Manufactured by: Wockhardt Limited, Mumbai, India; Distributed by: Wockhardt USA LLC., 20 Waterview Blvd., Parsippany, NJ 07054, USA; NDC 64679-735-09, UPC 3 64679 73509 1.
Reported: May 14, 2014 Initiated: April 1, 2014 #D-1300-2014
Product Description
Metoprolol Succinate Extended-Release Tablets, USP, 50 mg, 30-count bottle, Rx only, Manufactured by: Wockhardt Limited, Mumbai, India; Distributed by: Wockhardt USA LLC., 20 Waterview Blvd., Parsippany, NJ 07054, USA; NDC 64679-735-09, UPC 3 64679 73509 1.
Reason for Recall
Failed Dissolution Specifications: failure of dissolution test observed at nine month time point.
Details
- Recalling Firm
- Wockhardt Usa Inc.
- Units Affected
- 109,744 bottles
- Distribution
- Nationwide
- Location
- Parsippany, NJ
Frequently Asked Questions
What product was recalled? ▼
Metoprolol Succinate Extended-Release Tablets, USP, 50 mg, 30-count bottle, Rx only, Manufactured by: Wockhardt Limited, Mumbai, India; Distributed by: Wockhardt USA LLC., 20 Waterview Blvd., Parsippany, NJ 07054, USA; NDC 64679-735-09, UPC 3 64679 73509 1.. Recalled by Wockhardt Usa Inc.. Units affected: 109,744 bottles.
Why was this product recalled? ▼
Failed Dissolution Specifications: failure of dissolution test observed at nine month time point.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on May 14, 2014. Severity: Moderate. Recall number: D-1300-2014.
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