Class II · Moderate risk
Lansoprazole Delayed-Release Capsules USP
CGMP Deviations
Lansoprazole Delayed-release Capsules
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Presence of Foreign Tablets/Capsules: Bottles of lansoprazole 30 mg delayed-release capsules may contain topiramate 100 mg tablets.
Cause type: Particulate / foreign matter
Visible foreign particles - glass, metal, fibers or other material - found in the product. Particles can enter from equipment wear, containers or the process, and are dangerous in injectables. All particulate / foreign matter recalls.
What was recalled
Lansoprazole Delayed-release Capsules, USP, 30 mg, 500-count capsules per bottle, Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A., Made in India, NDC 0378-8030-05.
Affected NDC
0378-8030-05
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 00378-8030 |
30 mg/1 | Capsule, Delayed Release Pellets Oral |
Mylan Pharmaceuticals Inc. | Rx |
- Recalling firm
- Mylan Pharmaceuticals Inc.
- NDC code
- 0378-8030-05
- Origin
- WV, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-147-2013 · 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 Mylan Pharmaceuticals Inc.
All 2013 recalls
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Class II · Moderate risk
Mycophenolate Mofetil for Injection USP
Presence of precipitate
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