Aquarion preserved cartridges recalled over good manufacturing practice deviations
Encon Safety Products is recalling 7,677 bags of AQ 120 GFEW Aquarion Preserved Cartridges over cGMP deviations.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: Scored 2 as a precautionary recall: the record cites generic cGMP deviations with no named contaminant, defect or reported harm.
Plain-English summary
AQ 120 GFEW, Aquarion Preserved Cartridges, supplied as two cartridges of 3.7 gallons each, are being recalled by Encon Safety Products Co.
The reason given in the enforcement record is cGMP deviations.
The record lists 7,677 bags across lots 239066, 378106, 379202, 379750, 380983, 382901, 384682, 386189 and 387559, with further lots and their expiry dates recorded in the enforcement record. Distribution was nationwide within the United States. The FDA has classified the action as Class II.
The record cites manufacturing practice deviations without naming a specific defect or contaminant, and states no injuries. Users should follow the firm's instructions.
The recalled product
- Product
- AQ 120 GFEW, Aquarion Preserved Cartridges (2) 3.7 Gallons each
- Manufacturer
- Encon Safety Products Co
- Category
- Drug — Eyewash solution
- Affected units
- 7,677
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 (20)
- Lot #: 239066
- Exp. Date 1/24/2027
- 378106
- Exp. Date 3/8/2026
- 379202
- Exp. Date 3/29/2026
- 379750
- Exp. Date 4/24/2026
- 380983
- Exp. Date 5/24/2026
- 382901
- Exp. Date 7/11/2026
- 384682
- Exp. Date 8/16/2026
- 386189
- Exp. Date 9/20/2026
- 387559
- Exp. Date 10/11/2026
- 388381
- Exp. Date 11/2/2026
Distribution
Distributed nationwide across the United States.
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