Why it was recalled
CGMP Deviations: Downstream recall from Breckenridge Pharmaceuticals, Inc due to potential risk of Cross Contamination.
Product description
Alprazolam Tab, USP 0.25mg, (CIV), 30-count bottle, Rx Only, Preferred Pharmaceuticals, Inc. Manufactured by: Breckenridge Pharmaceuticals, Inc., Boca Raton, FL. Ins:NDC 68788-7594-3
Lot numbers, UPCs & expiration codes
Lot: G1822K, Exp. Date:5/31/2023.
Where it was sold
Nationwide in the USA
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-0504-2023
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Mar 27, 2023
- FDA report date
- Apr 12, 2023
- Quantity
- 30 Bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Preferred Pharmaceuticals, Inc.
Original FDA data
Every field from FDA enforcement report D-0504-2023, exactly as published.
Show all FDA fields
- City
- Anaheim
- State
- CA
- Status
- Terminated
- Country
- United States
- Event ID
- 92008
- Address
- 1250 N Lakeview Ave Ste O
- Code information
- Lot: G1822K, Exp. Date:5/31/2023.
- Postal code
- 92807-1801
- Report date
- Apr 12, 2023
- Product type
- Drugs
- Recall number
- D-0504-2023
- Classification
- Class II
- Recalling firm
- Preferred Pharmaceuticals, Inc.
- Product quantity
- 30 Bottles
- Termination date
- Oct 24, 2023
- Reason for recall
- CGMP Deviations: Downstream recall from Breckenridge Pharmaceuticals, Inc due to potential risk of Cross Contamination.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Alprazolam Tab, USP 0.25mg, (CIV), 30-count bottle, Rx Only, Preferred Pharmaceuticals, Inc. Manufactured by: Breckenridge Pharmaceuticals, Inc., Boca Raton, FL. Ins:NDC 68788-7594-3
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Mar 27, 2023
- Initial firm notification
- Letter
- Center classification date
- Apr 5, 2023