The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1522-2019·Announced 2019-07-31

Geritrex Recalls Gericare Diocto Liquid Stool Softener Due to Microbial Contamination Risk

Geritrex, LLC is recalling 6,165 bottles of Gericare Diocto Liquid Stool Softener due to cGMP deviations that may result in microbial contamination.

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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II and involves a risk of microbial contamination, which aligns with the rubric criteria for Severe severity (FDA Class II with potential for significant health impact).

Plain-English summary

Geritrex, LLC is voluntarily recalling 6,165 bottles of Gericare Diocto Liquid Docusate Sodium Stool Softener, 50 mg/5mL, 16 FL OZ (473 ml). The product is identified by Lot # 70612 and an expiration date of 6/19. The recall is being conducted because of Current Good Manufacturing Practice (cGMP) deviations that may have resulted in microbial contamination of the product.

The affected product was distributed nationwide in the United States by Gericare Pharmaceuticals corp. The recall is classified as FDA Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

Consumers who have purchased this specific lot of Gericare Diocto Liquid Stool Softener should stop using it and contact the recalling firm or their healthcare provider for further instructions.

The recalled product

Product
Gericare Diocto Liquid Docusate Sodium Stool Softener, 50 mg/5mL, 16 FL OZ (473 ml), Dist. BY: Gericare Pharmaceuticals corp. 1650 63rd Street Brooklyn, NY 11204, NDC 57896-403-16
Manufacturer
Geritrex, LLC
Category
Drug — Stool Softener
Hazard
Affected units
6,165

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 #: 70612
  • Exp 6/19

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 8 recalled by Geritrex, LLC 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 8 products in this recall →

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