Drug product
MEDIC EYE DROPS MAX REDNESS SKU 998920 CLR EYS MX RDNS RLIF 0.5 FL OZ SKU 901844 SYSTANE ULTRA HIGH PRFRM LUB DRPS 0.14 FLOZ SKU 901961 LUMIFY REDNESS REL EYE DROPS 2.5 FL OZ SKU 998300 FC EYE DROPS ADVANCED 0.5 OZ SKU 902280 distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.
D-1430-2022
Product summary
- Event
- Event 90566
- Status
- Ongoing
- Classification
- Class II
- Quantity
- Unknown
- Official record key
drug-enforcement:D-1430-2022
Official wording
Reason: CGMP Deviations: product held outside appropriate storage temperature conditions.
Code information: SKUs: 998920; 901844; 901961; 998300; 902280
Distribution pattern: Nationwide within the United States
Derived failure modes
-
Manufacturing or process control
CGMP Deviations