US Pharmaceuticals Recalls Children's Glycerin Suppositories for Water Quality Issues
US Pharmaceuticals is recalling 76 cases of Children Glycerin Suppositories due to out-of-specification results in the purified water used during manufacturing.
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 does not report any illnesses, injuries, or hospitalizations, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
US Pharmaceuticals Inc. is recalling 76 cases of Children Glycerin Suppositories Laxative for ages 2 to 5. The product is distributed by Walgreen Co. and carries the NDC number 0363-0440-25. The specific lot affected is #88J17 with an expiration date of 07/2019.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. Specifically, out-of-specification results were found for either total microbial count or total organic carbon in the purified water utilized in the manufacturing process. The agency has classified this recall as Class II.
The product was distributed nationwide in the USA. Consumers who have this product should stop using it and contact the distributor or manufacturer for further instructions.
The recalled product
- Product
- Children Glycerin Suppositories Laxative for ages 2 to 5. Package Size 25-count.Distributed by Walgreen CO. 200 Wilmot Rd. Deerfield IL 60015. NDC#0363-0440-25,
- Manufacturer
- US Pharmaceuticals Inc.
- Category
- Drug — Laxative
- Affected units
- 76
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 (1)
- Lot #88J17 EXP 07/2019
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 18 recalled by US Pharmaceuticals Inc. 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.
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