Class III · Low risk Terminated
Just Right 5000, 1.1% Sodium Fluoride, Candy Apple Flavor, Net Wt. 3.4oz (97g), Rx Only, Manufactured for Elevate Oral Care, LLC…
Reason LABELING: LABEL MIX-UP.
Colostat, Homeopathic Remedy, 1 fl. oz. (30 mL) per bottle, 20% Ethanol, Dist. by…
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Labeling mix-up - Indications on product label are incorrect.
What was recalled
Colostat, Homeopathic Remedy, 1 fl. oz. (30 mL) per bottle, 20% Ethanol, Dist. by Energique, Inc., 201 Apple Blvd., Woodbine, IA 51579, NDC 44911-0411-1
- Recalling firm
- Grato Holdings, Inc.
- NDC code
- 44911-0411-1
- Origin
- IA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1049-2020
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
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Class II · Moderate risk Terminated
Pantoprazole Sodium for Delayed-Release Oral Suspension*40 mg* suspension in apple juice or applesauce only Each packet contains…
Reason Discoloration
Class II · Moderate risk Ongoing
SOFTSOAP ANTI BACTRIAL LQ SOAP 11.25 FLOZ SKU 2005090 DIAL LHS WHITE TEA AND VITAMIN E 7.5FLOZ SKU 2007700 SOFTSOAP LHS CC…
Reason CGMP Deviations: product held outside appropriate storage temperature conditions.
Class II · Moderate risk Terminated
BEAK & SKIFF SANITIZER Alcohol Antiseptic 80%, Topical Solution Antiseptic Hand Rub Non-Sterile Solution, Packaged in a)…
Reason CGMP Deviations: FDA analysis found product to contain acetaldehyde above specification limits.
Class I · High risk Terminated
Hydro Pinapple Burn Max Health Thach Dua, packaged in a box containing 20g x 10 goi/sachets, MATXI CORP, UPC 8 936188 880108
Reason Marketed without an approved NDA/ ANDA - presence of undeclared sibutramine
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