Class I - Dangerous
CGMP Deviations; deficiencies observed during FDA inspection
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Other Drugs
💊 Drugs • 3,313 recalls
Class I - Dangerous
Defective container:may contain bottles with incomplete seals
Class I - Dangerous
Does Not Meet USP or OTC Monograph: Product did not meet the Over-the-Counter (OTC) Monograph M023
Cura Hongos, Crema Antifungica, Clotrimazole 1%, 2oz (57g) tubes, Dist by/por: Pharmadel LLC, New Castle, DE 19720, Made in India, UPC 8 52924 00683 1.
Dabur India Limited
Class I - Dangerous
CGMP Deviations; deficiencies observed during FDA inspection
Class I - Dangerous
CGMP Deviations; deficiencies observed during FDA inspection
Class I - Dangerous
Chemical Contamination: contamination with a diluted propylene glycol-based coolant from a machine leakage during the packaging process.
BEEKEEPER'S NATURALS Saline Nasal Spray, Sinus Congestion Rinse, Made with Propolis + Xylitol, 1 FL OZ (30 mL) per bottle, Manufactured For: Beekeeper's Naturals USA Inc., Covina, CA 91789.
BEEKEEPER'S NATURALS USA
Class I - Dangerous
Microbial Contamination of Non-Sterile Products
Class I - Dangerous
Microbial contamination of sterile products
Nicotine Transdermal System Patch, 14 mg, 14 patches per box, Aveva, Distributed by: RUGBY LABORATORIES, Indianapolis, IN 46268, www.majorpharmaceuticals.com, NDC 0536-5895-88.
AVEVA Drug Delivery Systems
Class I - Dangerous
Failed Impurities/Degradation Specifications: Elevated levels of oxidative-related impurities, exceeding shelf-life specifications during stability testing of individual units.
MG217 Multi-Symptom Treatment Cream & Skin Protectant (colloidal oatmeal 2%), NET WT 6 oz (170 g), Manufactured by: Pharmacal 1 Pharmacal Way, P.O. Box 198, Jackson, WI 53037.
Wisconsin Pharmacal Company
Class I - Dangerous
Microbial Contamination of Non-Sterile Products: confirmed presence of Staphylococcus Aureus.
Gas-X, Simethicone 125 mg/ ANTIGAS, 120 SoftGels, Distributed by: Haleon, Warren, NJ 07059, UPC: 3 00674 35041 9.
Haleon US Holdings
Class I - Dangerous
Labeling: Not Elsewhere Classified- Incomplete inactive ingredient information on the carton labeling.
DELFLEX, Dextrose Peritoneal Dialysis Solution with attached stay-safe Exchange Set for Intraperitoneal Dialysis Only, 2.5% DEX. LM/LC, 2L 5PK, Part Number 054-20222, Fresenius Medical Care North America, 920 Winter Street, Waltham, MA 02451.
Fresenius Medical Care Holdings
Class I - Dangerous
Lack of Assurance of Sterility: Potential leaks from perforations in bags.
DELFLEX, Dextrose Peritoneal Dialysis Solution with attached stay-safe Exchange Set for Intraperitoneal Dialysis Only, 1.5% DEX. LM/LC, 2L 5PK, Part Number 054-20221, Fresenius Medical Care North America, 920 Winter Street, Waltham, MA 02451.
Fresenius Medical Care Holdings
Class I - Dangerous
Lack of Assurance of Sterility: Potential leaks from perforations in bags.
Ketamine Hydrochloride Injectable Solution, 50mg/ml, (50 mg per mL) Volume: 1 mL, 5265 Kitty Drive, Houston, TX 77054, NDC 73702-302-31.
Wells Pharma of Houston
Class I - Dangerous
cGMP deviations.
fentaNYL Citrate Injectable Solution in 0.9% Sodium Chloride, 1000 mcg/50mL (20 mcg per mL), well pharma of Houston, NDC 73702-203-65.
Wells Pharma of Houston
Class I - Dangerous
cGMP deviations.
fentaNYL Citrate injectable Solution in 0.9% Sodium Chloride, Narcotic, (2500 mcg/ 250 mL) (10 mcg per mL), 250 mL bag, wells pharma of Houston, NDC 73702-202-03.
Wells Pharma of Houston
Class I - Dangerous
cGMP deviations.
fentaNYL Citrate Injectable Solution, NARCOTIC, Cii, 1000 mcg/100 mL (10 mcg per mL), 100 mL bag, Wells Pharma in Houston, NDC 73702-202-02.
Wells Pharma of Houston
Class I - Dangerous
cGMP deviations.
fentaNYL Citrate Injectable Solution, Narcotic, CII, 1250 mcg/25mL (50 mcg per mL), 25 mL, wells pharma of Houston, NDC 73702-204-25.
Wells Pharma of Houston
Class I - Dangerous
cGMP deviations.
Phenylephrine Hydrochloride Injectable Solution, 40mg, 250*mL Bag, wells pharma of Houston, NDC 73702-122-03
Wells Pharma of Houston
Class I - Dangerous
cGMP deviations.
fentaNYL Citrate Injectable Solution in 0.9% Sodium Chloride, 50 mcg/5mL)(10 mcg per mL), wells pharma, NDC 73702-202-15.
Wells Pharma of Houston
Class I - Dangerous
cGMP deviations.