Class II
Ongoing
Colic Calm, Colic, Gas & Reflux, Homeopathic Medicine, 2 Fl. Oz (59 ml) bottle. Distributed by Ketomi LLC, 1215 Sarasota Center Blvd., Sarasota FL 34240.
This recall is currently active, issued June 7, 2023. It was issued by Denison Pharmaceuticals, Llc.
- Company
- Denison Pharmaceuticals, Llc
- Recall Initiated
- May 3, 2023
- Posted
- June 7, 2023
- Recall Number
- D-0773-2023
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 54,222 bottles
- Firm Location
- Lincoln, RI, United States
- Official Source
- View on FDA website ↗
Reason for Recall
CGMP Deviations: Use of non-food grade lubricant in mixing vessel.
Distribution
Product was distributed Nationwide.
Lot / Code Info
Lot 8290V, Exp: 10-2023
More recalls by Denison Pharmaceuticals, Llc
Zapzyt, Acne Treatment Gel, 10% benzoyl peroxide Gel, packaged in 1 oz (28.35g) tube, Distributed by...
Mar 19, 2025 · Class II
Other recent Class II Drug recalls
Vista Tears Polyethylene Glycol 400 0.4% w/v, Propylene Glycol 0.3% w/v Eye Drops, Dry Eye Relief, L...
Wizcure Pharmaa Private Limited
· Mar 4, 2026
Amantadine HCl, Capsules, UPS, 100 mg, 50 Capsules (5 x 10) unit dose, Rx Only, Manufactured for: Av...
Avkare
· Mar 4, 2026
Agebox iKids-Growth (Day Formula) capsules, 60-count bottles, Manufactured Exclusively For: AGEBOX I...
Agebox
· Mar 4, 2026
Adbry, (tralokinumab-ldrm) injection, 300 mg/2mL, Packaged as a) 1 x Single dose Autoinjector, SAMPL...
Leo Pharma Inc
· Mar 4, 2026
Pro Numb Tattoo Numbing Spray, For Sensitive Skin, 4% Lidocaine, [1FL OZ/28.4 ML or 4 oz/120 mL] per...
Pro Numb Tattoo Numbing Spray Llc
· Feb 18, 2026