CLASS II Drug recall · Reported 26 Jun 2024 · FDA Enforcement Report
Little Remedies Gas Relief Drops (Simethicone/Antigas) recalled
Denison Pharmaceuticals is recalling Little Remedies Gas Relief Drops (Simethicone/Antigas). The recall was initiated on 28 May 2024 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0557-2024
- FDA event ID
- 94712
- Recalling firm
- Denison Pharmaceuticals, Lincoln, RI
- Brand
- Little Remedies
- Manufacturer
- Medtech Products Inc.
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 28 May 2024
- FDA classified
- 17 Jun 2024
- Reported
- 26 Jun 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- N/A
- Reason category
- Sterility
Timeline
| 28 May 2024 | Recall initiated by company | |
| 17 Jun 2024 | Classified by FDA | +20 days |
| 26 Jun 2024 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
cGMP deviations: Test results confirmed aypical Burkholderia Cepacia were a result of personnel error.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
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
Where it was distributed
Recalled units were distributed to one customer. 100% recovered (113,544 units) and controlled at Denison Pharmaceuticals.
Questions about this recall
Why was it recalled?
cGMP deviations: Test results confirmed aypical Burkholderia Cepacia were a result of personnel error.
Which lots are affected?
Lot #: 0855, Exp. 8/31/ 2025
Where was it sold?
Recalled units were distributed to one customer. 100% recovered (113,544 units) and controlled at Denison Pharmaceuticals.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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|---|---|---|---|---|---|
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