Recalls / Class II
Class IID-1313-2019
Product
INODERM Antiseptic Hand Soap (E-2), .6% (incorrectly labeled on bags as 75%) PCMX, 800ml/27fl.oz.pouches (NDC 058575-110), 12 x 800 Bag-N-Box pouches per case (NDC 058575-110-80), 5014-404-NB; INOPAK, 24 Executive PKWY, Ringwood, NJ 07456.
- Affected lot / code info
- Batch #: 7074
Why it was recalled
CGMP Deviations: hand sanitizers and soaps were not produced under current good manufacturing practices.
Recalling firm
- Firm
- Inopak Ltd
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 24 Executive Pkwy, N/A, Ringwood, New Jersey 07456-1430
Distribution
- Quantity
- 17,850 pounds per batch
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2019-04-22
- FDA classified
- 2019-05-29
- Posted by FDA
- 2019-06-05
- Terminated
- 2024-08-28
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1313-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.