FDA recall D-1372-2022

Family Dollar Stores, Llc. · Class II · 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.

Reason for recall

CGMP Deviations: product held outside appropriate storage temperature conditions.

Distribution

Nationwide within the United States

Key facts

Status
Ongoing
Initiation date
2022-06-23
Report date
2022-08-31
Voluntary/Mandated
Voluntary: Firm initiated
Location
Chesapeake, VA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1372-2022