Little Remedies Liquid
FDA Recall NDC 63029-103
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 Little Remedies (NDC 63029-103). A significant event, classified as Class II, was initiated on May 28, 2024 by Medtech Products Inc.. The reported reason for this action was: "cGMP deviations: Test results confirmed aypical Burkholderia Cepacia were a result of personnel error."
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: Test results confirmed aypical Burkholderia Cepacia were a result of personnel error.
May 28, 2024
Jun 26, 2024
113,544 bottles
Recall Profile & Regulatory Data
Event ID
94712
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Denison Pharmaceuticals, LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Recalled units were distributed to one customer. 100% recovered (113,544 units) and controlled at Denison Pharmaceuticals.
Termination Date
Aug 26, 2025
Product Description
Little Remedies Gas Relief Drops (Simethicone/Antigas), packaged in 1 fl. oz. (30 mL) bottle with dropper, Dist by Medtech Products Inc., Tarrytown, NY 10591, NDC 63029-103-02
Batch or Lot Expiration Information
Lot# : 0855, Exp. 8/31/ 2025
Affected Packages Involved in this Recall
63029-103-01Product
63029-103-02Product
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.
