Reported Jul 29, 2015 · Terminated
Lansoprazole Delayed-Release Capsules, USP, 30 mg Capsules, Packaged in A) 30 Count Bottles (NDC: 64679-0670-01), B) 90…
Wockhardt USA Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Wockhardt Usa Inc. · 20 Waterview Blvd Ste 3 · Parsippany, NJ · 07054-1271
Is this the product you have?
- Lansoprazole Delayed-Release Capsules, USP, 30 mg Capsules
- Packaged in A) 30 Count Bottles (NDC64679-0670-01)
- B) 90 Count Bottles (NDC64679-0670-07)
- and C) 1000 Count Bottles (NDC64679-0670-05), Rx only
- Manufactured byWockhardt Limited, Mumbai, India
- Distributed byWockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA
- Lot codes and dates
5 of 5 products
Products covered by this recall # Product as published 1 LN10933, Expiry: 4/30/2015 2 Lot #: LN10935, Expiry: 4/30/2015 3 Lot #: LN11063, Expiry: 4/30/2015. B) Lot #: LN10987, Expiry: 4/30/2015 4 Lot #: LN11415, Expiry: 6/30/2015. C) Lot #: LN10986, Expiry: 4/30/2015 5 Lot #: LN11414, Expiry: 6/30/2015. - Amount recalled
- A) 178,832 Bottles, B) 15,787 Bottles, and C) 459 Bottles.
This recall covers 35 products
The agency filed one notice per product. You are reading one of them; the other 34 are below.
22 more are in the archive.
Where it was sold
- Nationwide
- PR
Why it was recalled
CGMP Deviations: Firm did not adequately investigate customer complaints.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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