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 .
Reported: December 24, 2014 Initiated: April 17, 2014 #D-0304-2015
Product Description
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 .
Reason for Recall
Failed Dissolution Specifications: Product was out of specification (OOS) at the 12 month long term stability testing point.
Details
- Recalling Firm
- Wockhardt Usa Inc.
- Units Affected
- 1,118,400 extended release tablets
- Distribution
- Nationwide.
- Location
- Parsippany, NJ
Frequently Asked Questions
What product 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 .. Recalled by Wockhardt Usa Inc.. Units affected: 1,118,400 extended release tablets.
Why was this product recalled? ▼
Failed Dissolution Specifications: Product was out of specification (OOS) at the 12 month long term stability testing point.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on December 24, 2014. Severity: Low. Recall number: D-0304-2015.
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