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
AFCO recalled hand sanitizer on September 29, 2025, due to a risk of methanol contamination. The company failed to conduct required testing on incoming alcohol components. Consumers should stop using the product immediately.
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 recalled product is AFCO Hand Sanitizer, Product 5515. It is available in several configurations: 4x1 gallon cases, 5-gallon pails, and 55-gallon drums. The affected lot numbers include C2432725, C2508304, and C2509304 with expiration dates ranging from November 22, 2025, to April 3, 2026.
The recall stems from cGMP deviations, meaning the required testing for incoming alcohol components was not conducted. This raises the risk of methanol contamination, which can be harmful if ingested or absorbed through the skin.
No specific incidents or injuries have been reported related to this recall. However, the potential risks associated with methanol exposure are significant.
Consumers should immediately cease use of the recalled hand sanitizer. Contact Acuity Specialty Products at 800-345-1329 for guidance and possible returns.
For more information, visit the FDA recall page at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=D-0005-2026.
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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