Class II · Moderate risk
Lansoprazole Delayed-Release Capsules USP
CGMP Deviations
Lansoprazole Delayed-Release Orally Disintegrating Tablets 15 mg
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Failed Dissolution Specifications
Cause type: Dissolution failure
The tablet or capsule did not dissolve within specification. Dissolution controls how much drug the body absorbs; a failure can change the effective dose. All dissolution failure recalls.
What was recalled
Lansoprazole Delayed-Release Orally Disintegrating Tablets 15 mg, 100 Tablets (10x10 unit dose) blister pack, Rx only, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534 NDC 68382-771-77
Affected NDC
68382-0771-77
Compare with the code on your package — it is the most precise check available.
Drug: Lansoprazole
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Lansoprazole NDC 68382-0771 |
15 mg/1 | Tablet, Orally Disintegrating Oral |
Zydus Pharmaceuticals USA Inc. | Rx |
- Recalling firm
- Zydus Pharmaceuticals (USA) Inc
- NDC code
- 68382-771-77
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0145-2021 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Lansoprazole recalls
See all
Class II · Moderate risk
Lansoprazole Delayed-Release Capsules USP
CGMP Deviations: Inadequate induction sealing on bottles, capsules were observed with bubbles on band seal, capsules with holes and spheres sticking to capsules. Also coding details were missing on one bottle.
Class II · Moderate risk
Lansoprazole Delayed-Release Orally Disintegrating Tablets
FAILED DISSOLUTION SPECIFICATIONS
Class II · Moderate risk
Lansoprazole Delayed-Release Orally Disintegrating Tablets
FAILED DISSOLUTION SPECIFICATIONS
Class II · Moderate risk
PREVACID 24HR LANSOPRAZOLE 15MG CAP 14CT distributed to specific…
CGMP Deviations: product held outside appropriate storage temperature conditions.
Other recalls by Zydus Pharmaceuticals (USA) Inc
All 2020 recalls
Class II · Moderate risk
Mirabegron Extended-Release Tablets
CGMP: Due to Out of Specification (OOS) result for N-Nitroso Mirabegron impurity.
Class II · Moderate risk
Erythromycin Tablets
CGMP Deviations; presence of N-Nitroso-Desmethyl-Erythromycin above the recommended acceptable intake limit
Class II · Moderate risk
Erythromycin Tablets
CGMP Deviations; presence of N-Nitroso-Desmethyl-Erythromycin above the recommended acceptable intake limit
Class II · Moderate risk
Icosapent Ethyl Capsules
Failed Tablet/Capsule specifications: Red dots inside capsule and melted capsule caused by oxidized Icosapent ethyl, the active ingredient.
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