Colic Calm, Colic, Gas & Reflux, Homeopathic Medicine, 2 Fl. Oz (59 ml) bottle. Distributed by Ketomi LLC, 1215 Sarasota Center Blvd., Sarasota FL 34240.
Reported: June 7, 2023 Initiated: May 3, 2023 #D-0773-2023
Product Description
Colic Calm, Colic, Gas & Reflux, Homeopathic Medicine, 2 Fl. Oz (59 ml) bottle. Distributed by Ketomi LLC, 1215 Sarasota Center Blvd., Sarasota FL 34240.
Reason for Recall
CGMP Deviations: Use of non-food grade lubricant in mixing vessel.
Details
- Recalling Firm
- Denison Pharmaceuticals, LLC
- Units Affected
- 54,222 bottles
- Distribution
- Product was distributed Nationwide.
- Location
- Lincoln, RI
Frequently Asked Questions
What product was recalled? ▼
Colic Calm, Colic, Gas & Reflux, Homeopathic Medicine, 2 Fl. Oz (59 ml) bottle. Distributed by Ketomi LLC, 1215 Sarasota Center Blvd., Sarasota FL 34240.. Recalled by Denison Pharmaceuticals, LLC. Units affected: 54,222 bottles.
Why was this product recalled? ▼
CGMP Deviations: Use of non-food grade lubricant in mixing vessel.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on June 7, 2023. Severity: Moderate. Recall number: D-0773-2023.
Related Recalls
CPSC Moderate
Meijer Recalls Lullaby Lane and MCS Children's Sleepwear Due to Burn Hazard; Violates Mandatory Standard for Children's…
· 2026-02-19
FDA Food Moderate
Sea Moss Gel Superfood; 16 FL OZ; Glass jar sold individually. Passion Fruit- UPC# 5061033691882
Diva Fam Inc · 2026-02-11
FDA Food Moderate
Repackaged M&Ms candies, Net Wt 1.3 oz. Item BB458BG. Labeled with the following promotional company names. 1. Nex…
Beacon Promotions Inc · 2026-02-11
FDA Food Critical
Sofit, Seedless Red Dates, 12 oz package, Plastic bags, 50 packages per case
Tai Phat Wholesalers, LLC · 2026-02-11
FDA Food Moderate
Sea Moss Gel Superfood; 16 FL OZ; Glass jar sold individually. Wildcrafted- UPC# 5065006235073
Diva Fam Inc · 2026-02-11