US Pharmaceuticals Recalls Adult Glycerin Suppositories Due to Water Quality Issues
US Pharmaceuticals is recalling 196 cases of Adult Glycerin Suppositories because the purified water used in manufacturing failed quality tests for microbial count or organic carbon.
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 violation of labeling or manufacturing standards that may cause temporary or medically reversible health consequences. The source text does not report any illnesses, injuries, or fatalities, and the hazard is related to manufacturing deviations rather than a confirmed high-risk pathogen or structural defect.
Plain-English summary
US Pharmaceuticals Inc. is recalling 196 cases of Adult Glycerin Suppositories, 50-count packages, distributed by Walgreen Co. The affected products are identified by Lot #s 39P17, 42P17, 43P17, and 44P17, with an expiration date of 11/2019. The NDC number for the product is 0363-0441-50.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. Specifically, the purified water utilized in the manufacturing process yielded out-of-specification results for either total microbial count or total organic carbon. The products were distributed nationwide in the USA.
Consumers should check their medication for the specific lot numbers and expiration date listed above. If the product matches the recalled description, consumers should stop using it and contact their pharmacist or healthcare provider for guidance on disposal or replacement.
The recalled product
- Product
- Adult Glycerin Suppositories, Package Size 50-count suppositories, Distributed By: Walgreen Co. 200 Wilmot Rd. Deerfield, IL 60015. NDC#0363-0441-50
- Manufacturer
- US Pharmaceuticals Inc.
- Category
- Drug — Suppositories
- Affected units
- 196
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 (5)
- Lot #'s 39P17
- 42P17
- 43P17
- 44P17
- EXP 11/2019
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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