Ketamine Hydrochloride, 50mg/5 mL (10mg/mL), Injection for IV use, 50 mL syringe, STAQ Pharma Inc., 14135 E 42nd Ave, Denver, Colorado, NDC 73177-0156-02.
Labeling: Incorrect or Missing Lot and/or Exp Date
Acuity Specialty Products recalled its Wyandotte Sanifect E3 hand sanitizer on September 29, 2025. The recall affects multiple package configurations due to potential methanol contamination. Consumers should stop using the product immediately and contact the company for guidance.
cGMP deviations: The recall was initiated because required receipt testing of incoming alcohol components used to manufacture the listed hand sanitizers was not performed, so methanol risk could not be excluded.
Consumers and healthcare providers should stop using this product immediately. Contact Acuity Specialty Products, Inc. or your healthcare provider for guidance. Notification method: Letter
The recall includes Wyandotte Sanifect E3 hand sanitizer (Ethanol-Based, Product 5511) with ethyl alcohol 60.1%. It was sold in package configurations of 6x1000mL cases, 4x1 gallon cases, 5-gallon pails, and 55-gallon drums.
The recall was initiated due to cGMP deviations. Required testing of incoming alcohol components was not performed, which raises the risk of methanol contamination.
No injuries or incidents have been reported related to this recall. Methanol exposure can lead to serious health issues.
Stop using the product immediately. Consumers should contact Acuity Specialty Products or their healthcare provider for guidance.
For more information, call Acuity Specialty Products at 800-345-1329 or visit their website at [FDA Recall Notice](https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=D-0004-2026).
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Labeling: Incorrect or Missing Lot and/or Exp Date
CGMP Deviations: The recalling firm filed for Chapter 11 on September 30, 2024. As a result, it cannot monitor the quality program and hence cannot assure that products meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess, rendering the products adulterated.
Labeling: Incorrect or Missing Lot and/or Exp Date