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
CGMP Deviations: Firm did not adequately investigate customer complaints.
Cause type: cGMP deviation
Departures from current Good Manufacturing Practice found in production or during FDA inspection. A broad quality-system cause: the batch was made under conditions that fall short of FDA manufacturing standards. All cgmp deviation recalls.
What was recalled
Lansoprazole Delayed-Release Capsules, USP, 30 mg Capsules, Packaged in A) 30 Count Bottles (NDC: 64679-0670-01), B) 90 Count Bottles (NDC: 64679-0670-07), and C) 1000 Count Bottles (NDC: 64679-0670-05), Rx only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA.
Affected NDCs
64679-0670-01
64679-0670-05
64679-0670-07
Compare with the code on your package — it is the most precise check available.
Drug: Lansoprazole
- Recalling firm
- Wockhardt Usa Inc.
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1269-2015 · 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 Wockhardt Usa Inc.
All 2015 recalls
Class III · Low risk
Enalapril Maleate Tablets USP
Failed Impurities/Degradation Specifications
Class III · Low risk
Enalapril Maleate Tablets USP
Failed Impurities/Degradation Specifications
Class III · Low risk
Enalapril Maleate tablets
Failed Impurities/Degradation Specifications: 5mg strength being recalled for out of specification results for related compound.
Class II · Moderate risk
Lisinopril Tablets USP
CGMP Deviations: An FDA inspection identified inadequate investigations of past market complaints.
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