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Recall Observatory FDA recall evidence

Drug product

Senna (sennosides 8.8 mg) Syrup, 8 fl oz. (237 mL) bottles, Rij Pharmaceuticals Corporation 40 Commercial Avenue, Middletown, NY 10941, NDC 53807-556-08

D-1436-2019

May 06, 2019

Class II

Product summary

Firm
Geritrex, LLC
Event
Event 82947
Status
Terminated
Classification
Class II
Quantity
1536 units
Official record key
drug-enforcement:D-1436-2019

Official wording

Reason: Failed Impurities/Degradation Specifications: Atypical odor and unpleasant taste was reported

Code information: Lot #: 1804012, Exp. 08/2019

Distribution pattern: Nationwide within the United States

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    Failed Impurities/Degradation Specifications