Drug product
Premier Value Tussin Cough DM, Dextromethorphan HBr...Cough Suppressant, Guaifenesin...Expectorant, Alcohol Free, 8 FL OZ (237 mL) bottle, Distributed by: Pharmacy Value Alliance, LLC, 407 East Lancaster Avenue, Wayne PA 19087, UPC 8-40986-03789-4.
D-0215-2024
Product summary
- Event
- Event 93708
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 4,176 bottles
- Official record key
drug-enforcement:D-0215-2024
Official wording
Reason: CGMP Deviations: Firm reported possible microbial contamination in the purified water used in the manufacturing of the products. No contamination was found in the final products.
Code information: Lot # SD23033, Exp 04/30/2025
Distribution pattern: MI, PA
Derived failure modes
-
Manufacturing or process control
CGMP Deviations
-
Microbial contamination
microbial contamination