The Recall Desk
ModerateFDA (Drugs)·D-0852-2018·Announced 2018-06-20

RIJ Recalls Gericare Diocto Liquid Due to Microbial Count Deviation

RIJ Pharmaceutical LLC is recalling Gericare Diocto Liquid because a water sample showed an out-of-specification total aerobic microbial count.

What this means for you

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 reasonable probability that use may cause temporary or medically reversible health consequences. The hazard is a microbial count deviation in a water sample, which is a manufacturing quality issue rather than a confirmed high-risk pathogen or reported illness.

Plain-English summary

RIJ Pharmaceutical LLC is recalling Gericare Diocto Liquid (Docusate Sodium 50mg), 50 mg/5 mL, packaged in 16 FL OZ (473 mL) bottles. The recall involves 12,756 bottles distributed nationwide in the USA. The specific lots affected are 47080041 and 47080051, with an expiration date of 08/19.

The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. Specifically, an out-of-specification total aerobic microbial count was detected in a water sample. The product is distributed by Gericare Pharmaceuticals Corp.

Consumers should check their inventory for the specific lot numbers and expiration dates listed above. If they possess the affected product, they 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 50mg), 50 mg/5 mL, packaged in 16 FL OZ (473 mL) bottles, Dist by: Gericare Pharmaceuticals Corp. 1650 63rd Street, Brooklyn, NY 11204, NDC 57896-403-16, UPC 357896-403164,
Affected units
12,756

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 (3)

  • Lot #: 47080041
  • 47080051
  • Exp. 08/19

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 12 recalled by RIJ Pharmaceutical 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 12 products in this recall →