Drug product
DrKids Children's Natural Cough Syrup English Ivy Leaf, packaged in Pre-measured Single-Use Vials 0.17 fl. oz. (5 mL) Each 3.4 fl. oz. (100 mL), Manufactured in USA by: UNIPHARMA, LLC Tamarac, FL 33321 UPC 370302489026
D-0132-2020
Product summary
- Firm
- Unipharma, Llc.
- Event
- Event 83881
- Status
- Terminated
- Classification
- Class II
- Quantity
- 144 cartons
- Official record key
drug-enforcement:D-0132-2020
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: 80047 Exp. 07/31/20
Distribution pattern: U.S.A. Nationwide
Derived failure modes
-
Manufacturing or process control
CGMP Deviations