Why it was recalled
Failed Tablet/Capsule Specification: some capsules over time do not meet or are suspected to not meet the specification for acid resistance.
Product description
Omeprazole Delayed-Release Capsules, USP, 20 mg, Rx Only, 1000 Capsules per bottle, Distributed by: Kremers Urban Pharmaceuticals Inc. Princeton, NJ 08540, USA, NDC: 62175-118-43
Lot numbers, UPCs & expiration codes
Lot Number 59627; Expiration Date 02/2014
Where it was sold
KY & TN
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-009-2014
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Sep 16, 2013
- FDA report date
- Nov 27, 2013
- Quantity
- 3867 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Kremers Urban Pharmaceuticals, Inc.
Original FDA data
Every field from FDA enforcement report D-009-2014, exactly as published.
Show all FDA fields
- City
- Seymour
- State
- IN
- Status
- Terminated
- Country
- United States
- Event ID
- 66218
- Address
- 1101 C Ave W
- Code information
- Lot Number 59627; Expiration Date 02/2014
- Postal code
- 47274-3342
- Report date
- Nov 27, 2013
- Product type
- Drugs
- Recall number
- D-009-2014
- Classification
- Class II
- Recalling firm
- Kremers Urban Pharmaceuticals, Inc.
- Product quantity
- 3867 bottles
- Termination date
- May 9, 2014
- Reason for recall
- Failed Tablet/Capsule Specification: some capsules over time do not meet or are suspected to not meet the specification for acid resistance.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Omeprazole Delayed-Release Capsules, USP, 20 mg, Rx Only, 1000 Capsules per bottle, Distributed by: Kremers Urban Pharmaceuticals Inc. Princeton, NJ 08540, USA, NDC: 62175-118-43
- Distribution pattern
- KY & TN
- Recall initiation date
- Sep 16, 2013
- Center classification date
- Nov 20, 2013