Drug 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.
D-1313-2019
Product summary
- Firm
- Inopak Ltd
- Event
- Event 82645
- Status
- Terminated
- Classification
- Class II
- Quantity
- 17,850 pounds per batch
- Official record key
drug-enforcement:D-1313-2019
Official wording
Reason: CGMP Deviations: hand sanitizers and soaps were not produced under current good manufacturing practices.
Code information: Batch #: 7074
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Manufacturing or process control
CGMP Deviations