Inopak Recalls Hand Sanitizer Due to Manufacturing Practice Deviations
Inopak Ltd is recalling DermaGel and SaniTyze hand sanitizers because they were not produced under current good manufacturing practices.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the source text cites CGMP deviations without reporting specific illnesses, injuries, or deaths, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Inopak Ltd is voluntarily recalling specific batches of DermaGel Instant Waterless Hand Sanitizing Gel and SaniTyze Hand Sanitizer. The products are packaged in various sizes, including 1000 ml pouches, 2 fl. oz. bottles, 18 fl. oz. bottles, 8 fl. oz. bottles, 4 fl. oz. bottles, 800 ml pouches, and 1 gallon bottles.
The recall was initiated because the hand sanitizers and soaps were not produced under current good manufacturing practices (CGMP). The affected products contain 62% ethyl alcohol and are distributed nationwide in the USA. Specific batch numbers are listed in the official recall notice.
Consumers should stop using the recalled products and contact Inopak Ltd for further instructions or a refund. The products were manufactured by Inopak Ltd in Ringwood, NJ, and some were manufactured for Crosstex International, Inc. in Hauppauge, NY.
The recalled product
- Product
- Instant Waterless Hand Sanitizer, Ethyl Alcohol, 62%, packaged as a) DermaGel Instant Waterless Hand Sanitizing Gel with Moisturizers, with Aloe Vera & Vitamin E, packaged in a) 1000 ml Disc Pump pouches (NDC 58575-340), 8 x 1000 ml Disc Pump pouches per case, Product Code…
- Manufacturer
- Inopak Ltd
- Category
- Drug — Hand Sanitizer
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Batch #: 7069
- 6648
- 6649
- 6652
- 6654
- 6667
- 6669
- 6675
- 6677
- 6684
- 6686
- 6692
- 6694
- 6703
- 6704
- 6710
- 6717
- 6719
- 6726
- 6727
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 10 recalled by Inopak Ltd under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 10 products in this recall →Related recalls
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