Drug product
CORRECTDOSE Children's ALLERGY RELIEF (Diphenhydramine HCl 12.5 mg per 5 mL), 2.04 FL. OZ (60 mL) packaged in 12- 5mL individual doses, Distributed by Correct Dose Inc, Braintree MA 02184. NDC 62320-302-05 UPC 8 60003 67144 3
D-1492-2022
Product summary
- Event
- Event 90398
- Status
- Terminated
- Classification
- Class II
- Quantity
- 7,200 ampoules
- Official record key
drug-enforcement:D-1492-2022
Official wording
Reason: CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
Code information: Lot # 21011A, EXP Jan. 2023
Distribution pattern: Distributed Nationwide in the USA
Derived failure modes
-
Manufacturing or process control
CGMP Deviations