CVS Health Glycerin Suppositories Recalled for Water Quality Issues
US Pharmaceuticals is recalling CVS Health 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 situation where use of the product might cause temporary or medically reversible health consequences. The hazard involves water quality deviations (microbial/organic carbon) without reported illnesses, fitting the Moderate criteria for low-risk contamination or voluntary precautionary measures.
Plain-English summary
US Pharmaceuticals Inc. is recalling CVS Health Glycerin Suppositories, 100-count boxes, distributed by CVS Pharmacy, Inc. The recall involves 1,174 cases of the product that were distributed nationwide in the USA. The affected lots include specific expiration dates of 07/2019 and 11/2019, with lot numbers listed in the source data.
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.
Consumers who have purchased these specific lots of CVS Health Glycerin Suppositories should stop using the product and contact CVS Pharmacy or US Pharmaceuticals for further instructions or a refund.
The recalled product
- Product
- CVS Health Glycerin Suppositories, 100- count box, Distributed by:Distributed by: CVS Pharmacy, Inc. One CVS Drive Woonsocket, RI 02895. UPC 0 50428 42738 5
- Manufacturer
- US Pharmaceuticals Inc.
- Category
- Drug — Suppositories
- Affected units
- 1,174
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)
- Lot #'s 61J17
- 62J17
- 65J17
- 66J17
- 67J17
- 83J17
- 86J17
- 87J17 EXP 07/2019
- Lot #'s 06P17
- 08P17
- 09P17
- 10P17
- 12P17
- 13P17
- 15P17
- 16P17
- 17P17
- 18P17
- 19P17
- 21P17
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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