US Pharmaceuticals Recalls Walgreens Glycerin Suppositories for Water Quality Issues
US Pharmaceuticals is recalling 98 cases of Walgreens Adult 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 involves CGMP deviations regarding water quality (microbial count or organic carbon) without reported illnesses or injuries, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
US Pharmaceuticals Inc. is recalling 98 cases of Walgreens Adult Glycerin Suppositories (NDC 0363-0445-25). The affected product is a 25-count package of adult glycerin suppositories distributed by Walgreen Co. The recall involves Lot # 01K17 and 02K17, which have an expiration date of 08/2019.
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 product was distributed nationwide in the USA. Consumers who have this product should stop using it and contact their healthcare provider or pharmacist for further instructions.
The recalled product
- Product
- WALGREENS ADULT GLYCERIN (GLYCERIN SUPPOSITORY)
- Brand
- WALGREENS ADULT GLYCERIN
- Manufacturer
- US Pharmaceuticals Inc.
- Category
- Drug — OTC Suppositories
- Affected units
- 98
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 (2)
- Lot # 01K17
- 02K17 -Exp 08/2019
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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