Lansoprazole Delayed-Release Orally Disintegrating Tablets 15 mg, 100-count carton (10 x10 unit-dose), Rx only, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India, Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534, NDC 68382-771-77
Reported: November 11, 2020 Initiated: October 27, 2020 #D-0074-2021
Product Description
Lansoprazole Delayed-Release Orally Disintegrating Tablets 15 mg, 100-count carton (10 x10 unit-dose), Rx only, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India, Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534, NDC 68382-771-77
Reason for Recall
Failed Dissolution Specification
Details
- Recalling Firm
- Zydus Pharmaceuticals (USA) Inc
- Units Affected
- 6,840 units
- Distribution
- Distributed Nationwide in the USA
- Location
- Pennington, NJ
Frequently Asked Questions
What product was recalled? ▼
Lansoprazole Delayed-Release Orally Disintegrating Tablets 15 mg, 100-count carton (10 x10 unit-dose), Rx only, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India, Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534, NDC 68382-771-77. Recalled by Zydus Pharmaceuticals (USA) Inc. Units affected: 6,840 units.
Why was this product recalled? ▼
Failed Dissolution Specification
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on November 11, 2020. Severity: Moderate. Recall number: D-0074-2021.
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