The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0850-2018·Announced 2018-06-20

Geritrex Senna Syrup Recalled for Microbial Contamination

RIJ Pharmaceutical LLC is recalling Geritrex Senna Syrup due to out-of-specification microbial counts in a water sample.

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 and involves a CGMP deviation regarding microbial counts in a water sample, which fits the criteria for moderate severity involving low-risk contamination or voluntary precautionary measures without reported illness.

Plain-English summary

RIJ Pharmaceutical LLC is voluntarily recalling Geritrex Senna Syrup (sennosides 8.8mg) in 8 FL OZ. (236 mL) bottles. The recall is due to Current Good Manufacturing Practice (CGMP) deviations, specifically an out-of-specification total aerobic microbial count found in a water sample.

The affected product is distributed by Geritrex, LLC. The recall covers 31,411 bottles distributed nationwide in the USA. Affected lot numbers are 47060011, 47070031, and 47070041 with an expiration date of 09/18, and lot number 47080031 with an expiration date of 10/18.

Consumers should check their bottles for the listed lot numbers and expiration dates. If the product matches the recalled items, consumers should stop using it and contact the distributor or manufacturer for instructions on disposal or return.

The recalled product

Product
Geritrex Senna Syrup (sennosides 8.8mg), packaged in 8 FL OZ. (236 mL) bottle, Distributed by Geritrex, LLC 144 Kingsbridge Rd East Mt Vernon, NY 10550, 1-800-736-3437, NDC 54162-007-08, UPC 354162007088
Manufacturer
RIJ Pharmaceutical LLC
Category
Drug — Syrup
Hazard
Affected units
31,411

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 #: 47060011
  • 47070031
  • 47070041
  • Exp. 09/18
  • 47080031
  • Exp.10/18

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 →

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