Multiple eye drop products recalled due to improper storage conditions
Family Dollar Stores is recalling multiple eye drop products that were held outside appropriate storage temperature conditions. These products were distributed nationwide between April 30 and June 10, 2022.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is scored as High (3) because it involves a drug product where improper storage conditions create a potential risk of harm through compromised safety or efficacy. The FDA Class II classification with CGMP storage deviations indicates a significant manufacturing deviation, though no illnesses or injuries have been reported.
Plain-English summary
Family Dollar Stores, LLC is recalling five eye drop products that were stored outside appropriate temperature conditions. The recalled products are MEDIC EYE DROPS MAX REDNESS (SKU 998920), CLEAR EYES MAX REDNESS RELIEF (SKU 901844), SYSTANE ULTRA HIGH PERFORMANCE LUBRICATING DROPS (SKU 901961), LUMIFY REDNESS RELIEF EYE DROPS (SKU 998300), and FC EYE DROPS ADVANCED (SKU 902280).
The recall was issued due to Current Good Manufacturing Practice (CGMP) deviations: the products were held outside appropriate storage temperature conditions. Improper storage temperatures can compromise the safety and effectiveness of eye drop formulations.
These products were distributed nationwide to Family Dollar Stores between April 30, 2022 and June 10, 2022.
The recalled product
- 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 0
- Manufacturer
- Family Dollar Stores, Llc.
- Category
- Drug — Eye Drops
- Hazard
- temperature-deviation
- efficacy-loss
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- SKUs: 998920
- 901844
- 901961
- 998300
- 902280
Distribution
Distributed nationwide across the United States.
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