Why it was recalled
Failed Impurities/Degradation Specifications: Out-of-Specification results obtained for unknown impurities during stability testing.
Product description
Omeprazole Delayed-Release Capsules, USP, 20 mg, 1000 count bottles, Rx Only, distributed by Breckenridge Pharmaceutical, Inc., Berlin, CT, Manufactured by Tow Pharmaceutical Europe, S.L., Martorelles (Barcelona), Spain NDC 51991-643-10
Lot numbers, UPCs & expiration codes
Lot # 191659, exp. date 05/2021
Where it was sold
Product was distributed nationwide
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-0308-2021
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Mar 11, 2021
- FDA report date
- Mar 24, 2021
- Quantity
- 3,146 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Breckenridge Pharmaceutical, Inc
Original FDA data
Every field from FDA enforcement report D-0308-2021, exactly as published.
Show all FDA fields
- City
- Berlin
- State
- CT
- Status
- Terminated
- Country
- United States
- Event ID
- 87498
- Address
- 15 Massirio Dr Ste 201
- Code information
- Lot # 191659, exp. date 05/2021
- Postal code
- 06037-2352
- Report date
- Mar 24, 2021
- Product type
- Drugs
- Recall number
- D-0308-2021
- Classification
- Class II
- Recalling firm
- Breckenridge Pharmaceutical, Inc
- Product quantity
- 3,146 bottles
- Termination date
- Mar 23, 2022
- Reason for recall
- Failed Impurities/Degradation Specifications: Out-of-Specification results obtained for unknown impurities during stability testing.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Omeprazole Delayed-Release Capsules, USP, 20 mg, 1000 count bottles, Rx Only, distributed by Breckenridge Pharmaceutical, Inc., Berlin, CT, Manufactured by Tow Pharmaceutical Europe, S.L., Martorelles (Barcelona), Spain NDC 51991-643-10
- Distribution pattern
- Product was distributed nationwide
- Recall initiation date
- Mar 11, 2021
- Initial firm notification
- Letter
- Center classification date
- Mar 18, 2021