CVS Health Glycerin Suppositories Recalled for Water Quality Issues
US Pharmaceuticals is recalling CVS Health Glycerin Suppositories due to out-of-specification results for microbial count or organic carbon 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, but the source text does not report any illnesses or injuries, and the hazard involves manufacturing deviations in water quality rather than a confirmed high-risk pathogen or structural defect, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
US Pharmaceuticals Inc. is recalling CVS Health Glycerin Suppositories, 50-count boxes, distributed by CVS Pharmacy, Inc. The recall involves 144 cases of the product, which were distributed nationwide in the USA. The affected lots are 52J17, 53J17, 54J17, 55J17, 59J17, and 60J17, all with an expiration date of 07/2019.
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. These deviations indicate that the water used to produce the suppositories did not meet the required quality standards.
Consumers who have purchased these specific lots of CVS Health Glycerin Suppositories should stop using the product and return it to the place of purchase for a refund or contact the recalling firm for further instructions. The product is identified by the UPC 0 50428 33106 4.
The recalled product
- Product
- CVS Health Glycerin Suppositories, 50-count box, Distributed by: CVS Pharmacy, Inc. One CVS Drive Woonsocket, RI 02895. UPC 0 50428 33106 4
- Manufacturer
- US Pharmaceuticals Inc.
- Category
- Drug — Suppositories
- Affected units
- 144
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 (6)
- Lot #'s 52J17
- 53J17
- 54J17
- 55J17
- 59J17
- 60J17 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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