D-0760-2023 Class II Terminated
FDA drug recall D-0760-2023 was initiated by Alpha Aromatics on May 16, 2023 and is designated Class II. Reason for recall: CGMP Deviations: FDA analysis found product to contain acetaldehyde and acetal above specification limits. The recall status is terminated (terminated July 1, 2024). Affected quantity: 544 1 gallon bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- May 31, 2023
- Initiation Date
- May 16, 2023
- Termination Date
- July 1, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 544 1 gallon bottles
Product Description
FOAMING HAND SANITIZER, fresh mint scent, 62% alcohol, 1 Gallon / 3.78 Liters bottle, 290 Alpha Drive RIDC industrial Park, Pittsburgh, PA 15238,
Reason for Recall
CGMP Deviations: FDA analysis found product to contain acetaldehyde and acetal above specification limits.
Distribution Pattern
Product was distributed to one account in NC.
Code Information
Lot: 2020-013211 and 2020-013629, No EXP date on label.