Drug product
GUARDIAN ANTACID EX STRGTH TBLT FRT 96CT SKU 901379 GUARDIAN CHWABLE SMTHIES BRRY FSION 60CT SKU 999845 GS EFFERVESCENT ANTACID TABLET 36 CT SKU 913102 GUARDIAN ANTCD TBLT XTRA STGTH BRY 96 CT SKU 914109 GUARDIAN ANTCID TBLT REG STTH FRT 150 CT SKU 914726 GC ANTACID SUPREME CHERRY 12 FL OZ SKU 914112 GUARDIAN ANTD ULTR STRGTH 1000 FRT 72 CT SKU 902322 distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.
D-1414-2022
Product summary
- Event
- Event 90566
- Status
- Ongoing
- Classification
- Class II
- Quantity
- Unknown
- Official record key
drug-enforcement:D-1414-2022
Official wording
Reason: CGMP Deviations: product held outside appropriate storage temperature conditions.
Code information: SKUs: 901379; 999845; 913102; 914109; 914726; 914112; 902322
Distribution pattern: Nationwide within the United States
Derived failure modes
-
Manufacturing or process control
CGMP Deviations