Drug product
Acetaminophen Child Strawberry Oral Suspension (160 mg/5 ml), 4 FL OZ (118 mL) per bottle, MADE WITH PRIDE & CARE FOR H-E-B SAN ANTONIO, TX 78204. NDC: 37808-759-26
D-0593-2022
Product summary
- Event
- Event 88905
- Status
- Terminated
- Classification
- Class II
- Quantity
- 3,840 bottles
- Official record key
drug-enforcement:D-0593-2022
Official wording
Reason: CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
Code information: Batch: 1GK0905, Exp 01/31/2023
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Manufacturing or process control
CGMP Deviations