Drug product
Ready in case ACETAMINOPHEN PM CAPLETS 24 CT SKU 900559; TYLENOL CHILD GRAPE 4 FL OZ SKU 901600 TYLENOL CHILD ORAL SUSPENSION CHERRY 4 FO 913104 TYLENOL INFANTS DROPS DF CHERRY 1OZ SKU 999108 TYLENOL PM CAPLET 24 CT SKU 900603 TYLENOL EXTRA STRENGTH CAPLET 24 CT SKU 916986 TYLENOL 8HR MSL ACHE PAIN RD CAPLET 24 CT SKU 901155 distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.
D-1372-2022
Product summary
- Event
- Event 90566
- Status
- Ongoing
- Classification
- Class II
- Quantity
- Unknown
- Official record key
drug-enforcement:D-1372-2022
Official wording
Reason: CGMP Deviations: product held outside appropriate storage temperature conditions.
Code information: SKUs:900559; 901600; 913104; 999108; 900603; 916986; 901155
Distribution pattern: Nationwide within the United States
Derived failure modes
-
Manufacturing or process control
CGMP Deviations