PROMETHAZINE PLAIN ORAL SOLUTION 6.25MG/5ML 473ML; ; RX; SOLUTION (USUALLY NOT OTIC, OPTH, NASAL DROPS), Rx Only, NDC 0211-0927-16
Recall Number: D-0558-2021
Firm: Cardinal Health Inc.
Classification: Class II
Status: Terminated
Report Date: 20210602
Initiation Date: 20210315
Termination Date: 20240617
Reason for Recall
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Product Description
PROMETHAZINE PLAIN ORAL SOLUTION 6.25MG/5ML 473ML; ; RX; SOLUTION (USUALLY NOT OTIC, OPTH, NASAL DROPS), Rx Only, NDC 0211-0927-16