Senna Syrup
FDA Recall NDC 66424-562
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Senna Syrup (NDC 66424-562). A significant event, classified as Class II, was initiated on May 07, 2018 by Sda Laboratories, Inc.. The reported reason for this action was: "CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbial count in a water sample."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class II Terminated
CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbial count in a water sample.
May 07, 2018
Jun 20, 2018
3537 bottles
Recall Profile & Regulatory Data
Event ID
80053
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
RIJ Pharmaceutical LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
Termination Date
Apr 07, 2023
Product Description
SDA Senna Syrup (Sennosides 8.8mg), packaged in 8 FL. OZ. (236 mL) bottles, Distributed by SDA Laboratories 280 Railroad Avenue, Greenwich CT 06830, NDC 66424-562-08, UPC 366424562082
Batch or Lot Expiration Information
Lot# : 47070042, Exp. 09/18
Affected Packages Involved in this Recall
66424-562-08Product
3664245620Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
