Status
Terminated
Drug Enforcement D-0505-2023
CGMP Deviations: Downstream recall from Breckenridge Pharmaceuticals, Inc due to potential risk of Cross Contamination.
Classification
Class II
Report Date
April 12, 2023
Termination Date
October 24, 2023
Product Information
- 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.
- Product quantity
- 320 x 30-count; 46 x 60-count; 10 x 90-count bottles
- Reason for recall
- CGMP Deviations: Downstream recall from Breckenridge Pharmaceuticals, Inc due to potential risk of Cross Contamination.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide in the USA
Location & Firm
- Recalling firm
- Preferred Pharmaceuticals, Inc.
- Address
-
1250 N Lakeview Ave Ste O
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-0505-2023
- Event ID
- 92008
- Recall initiation date
- March 27, 2023
- Center classification date
- April 5, 2023
- Code info
- 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.
- More code info
- —