Drug product
GUARDIAN BISMUTH CHWBLE CHRY TABS 30 CTSKU 902321 RIC BISMUTH MAXIMUM STRENGTH 8 FL OZ SKU 914325 PEPTO BISMOL ORIGINAL 8 FL OZ SKU 914324 RIC BISMUTH REG STRENGTH CHERRY 8 FL OZ SKU 914781 PEPTO BISMOL CHERRY 8 FL OZ SKU 916063 PEPTO B LIQUID ORIGINAL TRAVEL 3.4 FL OZ SKU 999812 distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.
D-1448-2022
Product summary
- Event
- Event 90566
- Status
- Ongoing
- Classification
- Class II
- Quantity
- Unknown
- Official record key
drug-enforcement:D-1448-2022
Official wording
Reason: CGMP Deviations: product held outside appropriate storage temperature conditions.
Code information: SKUs: 902321; 914325; 914324; 914781; 916063; 999812
Distribution pattern: Nationwide within the United States
Derived failure modes
-
Manufacturing or process control
CGMP Deviations