Why it was recalled
CGMP Deviations: During manufacturing Solifenacin Succinate Tablets might convert to Solifenacin Tartrate Tablets.
Product description
Solifenacin Succinate Tablets, 10 mg, packaged in a) 30-count bottles (NDC 51991-894-33) and b) 90-count bottles (NDC 51991-894-90), Distributed by: Breckenridge Pharmaceutical, Inc. Boca Raton, FL 33487; Manufactured by: Piramal Enterprises Limited Plot No 67-70, Sector -2 Pithampur 454 775, Dist, Dhar Madhya Pradesh, INDIA
Lot numbers, UPCs & expiration codes
Lot #: a) 81253, 81272, Exp. Date 01/2021 and b) 81268, Exp. Date 01/2021
Where it was sold
Product was distributed nationwide within the United States.
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-1051-2020
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jan 24, 2020
- FDA report date
- Mar 25, 2020
- Quantity
- 11, 250 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Breckenridge Pharmaceutical, Inc
Original FDA data
Every field from FDA enforcement report D-1051-2020, exactly as published.
Show all FDA fields
- City
- Berlin
- State
- CT
- Status
- Terminated
- Country
- United States
- Event ID
- 85186
- Address
- 15 Massirio Dr Ste 201
- Code information
- Lot #: a) 81253, 81272, Exp. Date 01/2021 and b) 81268, Exp. Date 01/2021
- Postal code
- 06037-2352
- Report date
- Mar 25, 2020
- Product type
- Drugs
- Recall number
- D-1051-2020
- Classification
- Class II
- Recalling firm
- Breckenridge Pharmaceutical, Inc
- Product quantity
- 11, 250 bottles
- Termination date
- Oct 19, 2020
- Reason for recall
- CGMP Deviations: During manufacturing Solifenacin Succinate Tablets might convert to Solifenacin Tartrate Tablets.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Solifenacin Succinate Tablets, 10 mg, packaged in a) 30-count bottles (NDC 51991-894-33) and b) 90-count bottles (NDC 51991-894-90), Distributed by: Breckenridge Pharmaceutical, Inc. Boca Raton, FL 33487; Manufactured by: Piramal Enterprises Limited Plot No 67-70, Sector -2 Pithampur 454 775, Dist, Dhar Madhya Pradesh, INDIA
- Distribution pattern
- Product was distributed nationwide within the United States.
- Recall initiation date
- Jan 24, 2020
- Initial firm notification
- Letter
- Center classification date
- Mar 23, 2020