Status
Terminated
Drug Enforcement D-0506-2023
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 1mg, (CIV), packaged in: a) 30-count bottle (NDC 68788-7596-3), b) 60-count bottle (NDC68788-7596-6); Rx Only, Preferred Pharmaceuticals, Inc. Manufactured by: Breckenridge Pharmaceuticals, Inc., Boca Raton, FL.
- Product quantity
- 33 x 30-count; 78 x 60-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-0506-2023
- Event ID
- 92008
- Recall initiation date
- March 27, 2023
- Center classification date
- April 5, 2023
- Code info
- Lot # a) H3122D, Exp. Date:8/31/2024; b) Lot #A1123R, L0522E, J2622H, I1622F, H2422E, Exp. Date:8/31/2024.
- More code info
- —