Rabeprazole Sodium Delayed Release Tablets, 20 mg, a) 30-count bottle (NDC 65162-0724-03), b) 90-count bottle (NDC 65162-0724-09), Rx Only, Manufactured by Amneal Pharmaceuticals Pvt. Ltd., Ahmedabad INDIA 382220, Distributed by Amneal Pharmaceuticals, Bridgewater, NJ 08807
Reported: May 10, 2017 Initiated: December 12, 2016 #D-0693-2017
Product Description
Rabeprazole Sodium Delayed Release Tablets, 20 mg, a) 30-count bottle (NDC 65162-0724-03), b) 90-count bottle (NDC 65162-0724-09), Rx Only, Manufactured by Amneal Pharmaceuticals Pvt. Ltd., Ahmedabad INDIA 382220, Distributed by Amneal Pharmaceuticals, Bridgewater, NJ 08807
Reason for Recall
Failed Dissolution Specifications
Details
- Recalling Firm
- Amneal Pharmaceuticals LLC
- Units Affected
- 105,215 Bottles
- Distribution
- Nationwide within the US and PR
- Location
- Glasgow, KY
Frequently Asked Questions
What product was recalled? ▼
Rabeprazole Sodium Delayed Release Tablets, 20 mg, a) 30-count bottle (NDC 65162-0724-03), b) 90-count bottle (NDC 65162-0724-09), Rx Only, Manufactured by Amneal Pharmaceuticals Pvt. Ltd., Ahmedabad INDIA 382220, Distributed by Amneal Pharmaceuticals, Bridgewater, NJ 08807. Recalled by Amneal Pharmaceuticals LLC. Units affected: 105,215 Bottles.
Why was this product recalled? ▼
Failed Dissolution Specifications
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on May 10, 2017. Severity: Moderate. Recall number: D-0693-2017.
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