D-0490-2022 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- February 9, 2022
- Initiation Date
- January 24, 2022
- Termination Date
- October 16, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2,685,700 packets
Product Description
DILOTAB II, SINUS AND COLD RELIEF NON DROWSY (acetaminophen 325 mg, Phenylephrine HCl 5 mg) 2 tablet packets, Dist. by ZEE Medical Distributors, LLC Mason, OH 45040, NDC 42961-052-03
Reason for Recall
cGMP deviations
Distribution Pattern
Nationwide within the United States
Code Information
Lot #: AK9548, (L) 106, Exp. Date 04/2022; AK9647, (L)103, Exp. Date 06/2022; AK9598, Exp. Date 05/2022