Esomeprazole Magnesium for Delayed-Release Oral Suspension, 20 mg, 30-count single dose packets per carton, Rx Only, Manufactured by: Zydus Lifesciences Ltd. Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 68382-848-94
Reported: May 28, 2025 Initiated: May 13, 2025 #D-0443-2025
Product Description
Esomeprazole Magnesium for Delayed-Release Oral Suspension, 20 mg, 30-count single dose packets per carton, Rx Only, Manufactured by: Zydus Lifesciences Ltd. Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 68382-848-94
Reason for Recall
Failed Impurities/Degradation Specifications: Out-of-Specification test results obtained for any individual unknown degradation product during Related Compounds testing during long term stability.
Details
- Recalling Firm
- Zydus Pharmaceuticals (USA) Inc
- Units Affected
- 22,152 30 sachets/carton
- Distribution
- Nationwide -in the USA
- Location
- Pennington, NJ
Frequently Asked Questions
What product was recalled? ▼
Esomeprazole Magnesium for Delayed-Release Oral Suspension, 20 mg, 30-count single dose packets per carton, Rx Only, Manufactured by: Zydus Lifesciences Ltd. Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 68382-848-94. Recalled by Zydus Pharmaceuticals (USA) Inc. Units affected: 22,152 30 sachets/carton.
Why was this product recalled? ▼
Failed Impurities/Degradation Specifications: Out-of-Specification test results obtained for any individual unknown degradation product during Related Compounds testing during long term stability.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on May 28, 2025. Severity: Moderate. Recall number: D-0443-2025.
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