Drug product
CORRECTDOSE Children's COUGH & CHEST CONGESTION DM (Guaifenesin 100 mg / Dextromethorphan 5 mg per 5 mL) 2.04FL. OZ (60mL), packaged in 12-5 individual doses, Distributed by Correct Dose Inc, Braintree MA 02184. NDC 62320-321-05 UPC 8 60003 67146 7
D-1494-2022
Product summary
- Event
- Event 90398
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1,464 ampoules
- Official record key
drug-enforcement:D-1494-2022
Official wording
Reason: CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
Code information: Lot # 21014A, EXP Feb. 2023
Distribution pattern: Distributed Nationwide in the USA
Derived failure modes
-
Manufacturing or process control
CGMP Deviations