Why it was recalled
CGMP Deviations: Downstream recall from Breckenridge Pharmaceuticals, Inc due to potential risk of Cross Contamination.
Product description
Alprazolam Tab, USP 0.5mg, (CIV), packaged in: a) 30-count bottle (NDC 68788-7595-3), b) 60-count bottle (NDC 68788-7595-6), c) 90-count bottle (NDC 68788-7595-9); Rx Only, Preferred Pharmaceuticals, Inc. Manufactured by: Breckenridge Pharmaceuticals, Inc., Boca Raton, FL.
Lot numbers, UPCs & expiration codes
Lot # a) D2022P, Exp. Date:4/30/2023; F1022Y, E2022, I2822U, Exp. Date:6/30/2023; L2122W, Exp. Date: 8/31/2024; b) Lot #L0522A, Exp. Date:8/31/2024; B0823J, Exp. Date:11/31/2024; c) Lot# L1522P, Exp. Date: 10/31/2024.
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-0505-2023
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Mar 27, 2023
- FDA report date
- Apr 12, 2023
- Quantity
- 320 x 30-count; 46 x 60-count; 10 x 90-count bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Preferred Pharmaceuticals, Inc.
Original FDA data
Every field from FDA enforcement report D-0505-2023, 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 # a) D2022P, Exp. Date:4/30/2023; F1022Y, E2022, I2822U, Exp. Date:6/30/2023; L2122W, Exp. Date: 8/31/2024; b) Lot #L0522A, Exp. Date:8/31/2024; B0823J, Exp. Date:11/31/2024; c) Lot# L1522P, Exp. Date: 10/31/2024.
- Postal code
- 92807-1801
- Report date
- Apr 12, 2023
- Product type
- Drugs
- Recall number
- D-0505-2023
- Classification
- Class II
- Recalling firm
- Preferred Pharmaceuticals, Inc.
- Product quantity
- 320 x 30-count; 46 x 60-count; 10 x 90-count 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 0.5mg, (CIV), packaged in: a) 30-count bottle (NDC 68788-7595-3), b) 60-count bottle (NDC 68788-7595-6), c) 90-count bottle (NDC 68788-7595-9); Rx Only, Preferred Pharmaceuticals, Inc. Manufactured by: Breckenridge Pharmaceuticals, Inc., Boca Raton, FL.
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Mar 27, 2023
- Initial firm notification
- Letter
- Center classification date
- Apr 5, 2023