Every FDA drug enforcement recall Public Health Trace has on record, republished from
openFDA's official drug enforcement database. See Health
Alerts for current, active recalls alongside outbreaks and advisories.
Drug recall information is sourced from the FDA's structured openFDA Enforcement
Reports. Newly announced recalls may appear on FDA.gov before they become available in
the structured dataset. See Methodology for how Public
Health Trace imports and refreshes this data.
Just Right 5000, 1.1% Sodium Fluoride, Candy Apple Flavor, Net Wt. 3.4oz (97g), Rx Only, Manufactured for Elevate Oral Care, LLC in the U.S.A with imported pump, 346 Pike Rd, Suite 5, West Palm Beach, FL 33411, NDC 57511-002-1
by Elevate Oral Care
Reason
LABELING: LABEL MIX-UP.
Recall initiated
August 20, 2024
Reported by FDA
September 18, 2024
Distribution
120 direct customers, Nationwide US. No foreign, DOD/VA.
Heparin (Heparin Sodium in 0.9% Sodium Chloride Injection), 2,000 units per 1,000 mL (2 units/mL), 1000 mL Sterile Single Dose Container, Rx Only, Baxter USA, NDC 0338-0433-04
by Baxter Healthcare Corporation
Reason
Microbial Contamination of Sterile Products; out of limit results obtained for endotoxin testing.
IBU Ibuprofen Tablets, USP, 400 mg, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, a) NDC 55111-682-01 - 100 Tablets per bottle, b) NDC 55111-682-05 - 500 Tablets per bottle.
by Dr. Reddy's Laboratories, Inc.
Reason
Failed impurities/degradation specifications: results for unknown impurity, were 0.13% and 0.11% respectively, exceeding the 0.10% specification limit.
IBU Ibuprofen Tablets, USP, 600 mg, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, a)NDC 55111-683-01 - 100 Tablets per bottle, b)NDC 5511-683-05 - 500 Tablets per bottle.
by Dr. Reddy's Laboratories, Inc.
Reason
Failed impurities/degradation specifications: results for unknown impurity, were 0.13% and 0.11% respectively, exceeding the 0.10% specification limit.
IBU Ibuprofen Tablets, USP, 800 mg, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, a)NDC 55111-684-01 - 100 Tablets per bottle, b)NDC 55111-684-05 - 500 Tablets per bottle.
by Dr. Reddy's Laboratories, Inc.
Reason
Failed impurities/degradation specifications: results for unknown impurity, were 0.13% and 0.11% respectively, exceeding the 0.10% specification limit.
This information is republished from FDA's Recall Enterprise System through openFDA. Public Health Trace
does not verify or supplement it, is not affiliated with the FDA, and does not provide medical advice --
always follow the guidance of your pharmacist, physician, or the recalling company for any medication you take.
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