D-0215-2024 Class II Ongoing
FDA drug recall D-0215-2024 was initiated by Seaway Pharma Inc. on December 28, 2023 and is designated Class II. Reason for recall: 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. The recall status is ongoing. Affected quantity: 4,176 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- January 10, 2024
- Initiation Date
- December 28, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4,176 bottles
Product Description
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.
Reason for Recall
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.
Distribution Pattern
MI, PA
Code Information
Lot # SD23033, Exp 04/30/2025