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
Reported: June 26, 2024 Initiated: May 28, 2024 #D-0557-2024
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
Reason for Recall
cGMP deviations: Test results confirmed aypical Burkholderia Cepacia were a result of personnel error.
Details
- Recalling Firm
- Denison Pharmaceuticals, LLC
- Units Affected
- 113,544 bottles
- Distribution
- Recalled units were distributed to one customer. 100% recovered (113,544 units) and controlled at Denison Pharmaceuticals.
- Location
- Lincoln, RI
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Denison Pharmaceuticals, LLC. Units affected: 113,544 bottles.
Why was this product recalled? ▼
cGMP deviations: Test results confirmed aypical Burkholderia Cepacia were a result of personnel error.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on June 26, 2024. Severity: Moderate. Recall number: D-0557-2024.
Related Recalls
CPSC Moderate
Huaker Magnetic Balls and Rods Sets Recalled Due to Risk of Serious Injury or Death from Choking; Violates the Small Ba…
Shenzhen Huakechuang Technology Co. Ltd., dba Huaker, of China · 2026-02-19
CPSC Moderate
JJGoo LED Balloon Lights Recalled Due to Risk of Serious Injury or Death from Battery Ingestion; Violates Mandatory Sta…
Shenzhen Yimu Technology Co., Ltd. dba JJGoo, of China · 2026-02-19
CPSC Moderate
Joly's Recalls 80% Vinegar Due to Risk of Serious Injury or Death from Poisoning and Chemical Burns; Violates FHSA Labe…
Joly's LLC, of Orlando, Florida · 2026-02-19
CPSC Moderate
Prismatic 3D Prints Recalls Book Nooks Due to Risk of Serious Injury or Death Battery Ingestion; Violates Mandatory Sta…
Prismatic 3D Prints LLC of Loveland, Colorado · 2026-02-19
CPSC Moderate
SAMIT Youth Multi-Purpose Helmets Recalled Due to Risk of Serious Injury or Death from Head Injury; Violates Mandatory …
Shenzhenshilonghuaqujialebeibaihuoshanghang (Jialebei Department Store, Longhua District, Shenzhen) dba Samit Outdoor, of China · 2026-02-19