May 2024 FDA Recall Little Remedies by Denison Pharmaceuticals, Llc
D-0557-2024 - cGMP deviations

This Class II drug recall was voluntarily initiated by Denison Pharmaceuticals, Llc on May 28, 2024 for the product Little Remedies. The FDA reported the reason for recall as cgmp deviations. The product was distributed in Recalled units were distributed to one customer. 100% recovered (113,544 units) and controlled at Denison Pharmaceuticals. and the recall is currently terminated.

Recall Number: D-0557-2024

Reason for Recall
cGMP deviations: Test results confirmed aypical Burkholderia Cepacia were a result of personnel error.
Initiated
05-28-2024
Reported
06-26-2024
Quantity
113,544 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
94712
Classification About Classification
Relative degree of health hazard assigned by FDA.
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Denison Pharmaceuticals, LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
N/A
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Recalled units were distributed to one customer. 100% recovered (113,544 units) and controlled at Denison Pharmaceuticals.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
08-26-2025
Product Description About Product Description
Full technical description of the product.
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

63029-103-01 Little Remedies Gas Relief Drops
63029-103-02 Little Remedies Gas Relief Drops