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.
Reported: June 5, 2019 Initiated: April 22, 2019 #D-1313-2019
Product Description
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.
Reason for Recall
CGMP Deviations: hand sanitizers and soaps were not produced under current good manufacturing practices.
Details
- Recalling Firm
- Inopak Ltd
- Units Affected
- 17,850 pounds per batch
- Distribution
- Nationwide in the USA
- Location
- Ringwood, NJ
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Inopak Ltd. Units affected: 17,850 pounds per batch.
Why was this product recalled? ▼
CGMP Deviations: hand sanitizers and soaps were not produced under current good manufacturing practices.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on June 5, 2019. Severity: Moderate. Recall number: D-1313-2019.
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