Geritrex Recalls Preferred Plus Dioctyl Liquid Stool Softener Due to Microbial Contamination
Geritrex, LLC is recalling Preferred Plus Dioctyl 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 potential 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 recalling Preferred Plus Dioctyl Liquid Stool Softener (Docusate Sodium), 50mg/5mL, 16 FL. Oz. (1 PT.) 473 mL. The product is manufactured by RIJ Pharmaceutical Corp. and distributed by Kinray Inc. The recall involves 15,435 bottles distributed nationwide in the U.S.A.
The recall was initiated due to Current Good Manufacturing Practice (cGMP) deviations. These deviations mean that the products may have microbial contamination. The affected lots are 70603, 70604, and 70612, all with an expiration date of 6/19.
Consumers who have this product should check their lot numbers and expiration dates. If the product matches the recalled lots, consumers should stop using it and contact the recalling firm or their healthcare provider for further instructions.
The recalled product
- Product
- Preferred Plus Dioctyl Liquid Stool Softener (Docusate Sodium), 50mg/5mL, 16 FL. Oz. (1 PT.) 473 mL, Manufactured by RIJ Pharmaceutical Corp. 40 Commercial Avenue Middletown, NY 10941, Distributed by Kinray Inc. Whitestone, NY 11357, NDC 53807-216-16
- Manufacturer
- Geritrex, LLC
- Category
- Drug — Liquid Stool Softener
- Hazard
- Affected units
- 15,435
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 (4)
- Lot #: 70603
- 70604
- 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.
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