Recall Enforment Report D-1437-2019

Recall Details

Multi event Drug Recall Enforcement Report Class II voluntary initiated by Geritrex, LLC, originally initiated on 05-06-2019 for the product Senna (sennosides 8.8 mg) Syrup 8 fl oz. (236 mL) bottles, Distributed by Geritrex, LLC 40 Commercial Avenue Middletown, NY 10941, NDC 54162-007-08 The product was recalled due to failed impurities/degradation specifications: atypical odor and unpleasant taste was reported. The product was distributed nationwide and the recall is currently terminated.

Recall Enforcement Reports

Recall Number Recall Initiation Date Report Date Recall Classification Quantity Product Description Recall Reason Status
D-1437-201905-06-201906-19-2019Class II24312 unitsSenna (sennosides 8.8 mg) Syrup 8 fl oz. (236 mL) bottles, Distributed by Geritrex, LLC 40 Commercial Avenue Middletown, NY 10941, NDC 54162-007-08Failed Impurities/Degradation Specifications: Atypical odor and unpleasant taste was reportedTerminated
D-1436-201905-06-201906-19-2019Class II1536 unitsSenna (sennosides 8.8 mg) Syrup, 8 fl oz. (237 mL) bottles, Rij Pharmaceuticals Corporation 40 Commercial Avenue, Middletown, NY 10941, NDC 53807-556-08Failed Impurities/Degradation Specifications: Atypical odor and unpleasant taste was reportedTerminated