Jaloma Antiseptic Hand Sanitizer Recalled for cGMP Deviations
Laboratorios Jaloma is recalling 211,875 bottles of Jaloma Antiseptic Hand Sanitizer due to current Good Manufacturing Practice (cGMP) deviations.
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, which typically indicates a situation where use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences. The source text does not report any specific illnesses or injuries, and the hazard is related to manufacturing deviations rather than a specific contamination event with reported harm.
Plain-English summary
Laboratorios Jaloma S.A. de C.V. is voluntarily recalling 211,875 bottles of Jaloma Antiseptic Hand Sanitizer, Ethyl Alcohol 62% with Vitamin E. The recall was initiated on July 31, 2020, and was classified as Class II by the FDA. The product is available in 16.9 Fl. Oz. (500 mL) and 4 Fl. Oz. (120 mL) bottles.
The reason for the recall is current Good Manufacturing Practice (cGMP) deviations. The affected lots include 0005295, 0006373, 0005412, 0007134, 0007834, and 0009239, with expiration dates ranging from April 2022 to June 2022. The product was distributed nationwide in the United States and Canada.
Consumers who have purchased this product should stop using it and contact the recalling firm for instructions on how to return the product or obtain a refund. The recall status is currently terminated.
The recalled product
- Product
- Jaloma Antiseptic Hand Sanitizer, Ethyl Alcohol 62% with Vitamin E, packaged in a) 16.9 Fl. Oz. (1.06 pint, 500 mL), NDC# 65055-600-02, UPC# 759684515033, b) 4 Fl. Oz.(120 mL), NDC# 65055-600-01, UPC# 75968455026, Laboratorios Jaloma S.A. DE C.V., Aquiles Serdan 438, Z.P. 44380…
- Manufacturer
- Laboratorios Jaloma S.A. de C.V.
- Category
- Drug — Hand Sanitizer
- Hazard
- Affected units
- 211,875
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 (9)
- Lot # a) 0005295
- Exp 4/2022
- 0006373
- Exp 5/2022
- b 0005412
- 0007134
- 0007834
- 0009239
- Exp 6/2022
Distribution
Distributed nationwide across the United States.
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