PROMETHAZINE PLAIN ORAL SOLUTION 6.25MG/5ML 473ML; ; RX; SOLUTION (USUALLY NOT OTIC, OPTH, NASAL DROPS), Rx Only, NDC 0211-0927-16
Reported: June 2, 2021 Initiated: March 15, 2021 #D-0558-2021
Product Description
PROMETHAZINE PLAIN ORAL SOLUTION 6.25MG/5ML 473ML; ; RX; SOLUTION (USUALLY NOT OTIC, OPTH, NASAL DROPS), Rx Only, NDC 0211-0927-16
Reason for Recall
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Details
- Recalling Firm
- Cardinal Health Inc.
- Units Affected
- 49 CARTON
- Distribution
- FL, GA, SC
- Location
- Dublin, OH
Frequently Asked Questions
What product was recalled? ▼
PROMETHAZINE PLAIN ORAL SOLUTION 6.25MG/5ML 473ML; ; RX; SOLUTION (USUALLY NOT OTIC, OPTH, NASAL DROPS), Rx Only, NDC 0211-0927-16. Recalled by Cardinal Health Inc.. Units affected: 49 CARTON.
Why was this product recalled? ▼
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on June 2, 2021. Severity: Moderate. Recall number: D-0558-2021.
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