The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-1730-2019·Announced 2019-08-21

US Pharmaceuticals Recalls Adult Glycerin Suppositories for Water Quality Issues

US Pharmaceuticals is recalling 880 cases of Adult Glycerin Suppositories because 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 involves a temporary or medically reversible adverse health consequence. The hazard is a manufacturing deviation (water quality) without reported illnesses, fitting the Moderate category for low-risk contamination or voluntary precautionary recalls.

Plain-English summary

US Pharmaceuticals Inc. is recalling 880 cases of Adult Glycerin Suppositories (NDC#0363-0441-00). The product is distributed by Walgreen Co. and was available nationwide in the United States. The recall involves specific lots with expiration dates of 07/2019 and 11/2019.

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.

Consumers who have these products should stop using them and return them to the point of purchase or contact the recalling firm for instructions. The source text does not report any illnesses or injuries associated with this recall.

The recalled product

Product
Adult Glycerin Suppositories, Package Size 100-count suppositories, Distributed By: Walgreen Co. 200 Wilmot Rd. Deerfield, IL 60015. NDC#0363-0441-00
Manufacturer
US Pharmaceuticals Inc.
Category
Drug — Suppositories
Hazard
Affected units
880

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 (19)

  • Lot #'s 68J17
  • 71J17
  • 72J17
  • 73J17
  • 77J17
  • 78J17
  • 79J17
  • 81J17
  • 82J17 - EXP 07/2019
  • 27P17
  • 28P17
  • 29P17
  • 30P17
  • 31P17
  • 32P17
  • 33P17
  • 37P17
  • 38P17
  • 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.

See all 18 products in this recall →

Related recalls

Same manufacturer · US Pharmaceuticals Inc.

See all →

Same hazard · contamination

See all →

Similar recalls