Drug product
DrKids Children's Cough & Chest Congestion DM, Dextromethorphan HBr 5 mg Guaifenesin 100 mg Mixed Berry Flavor 20 Pre-measured Singe-Use 0.17 fl. oz. (5 mL), Manufactured in USA by: Unipharma, LLC. Tamarac, FL 33321, NDC 70302-013-20, UPC 370302268010
D-1301-2019
Product summary
- Firm
- Unipharma, Llc.
- Event
- Event 82754
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1344 cartons
- Official record key
drug-enforcement:D-1301-2019
Official wording
Reason: CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination with the bacteria B. cepacia.
Code information: Lot: 80054 Exp. 10/31/20
Distribution pattern: Nationwide and Venezuela
Derived failure modes
-
Manufacturing or process control
CGMP Deviations