April 21, 2021DrugsFDA
Spartan Chemical Co Inc recalls Lite'n Foamy Healthcare Personnel Handwash (Chloroxylenol, 1.0%), Net Contents: 18 oz/ 532 ml per foam pump container, F
Hazard: CGMP Deviations
April 21, 2021DrugsFDA
Spartan Chemical Co Inc recalls Lite'n Foamy Eucalyptus Mint Sanitizing Handwash (Benzalkonium Chloride, 0.13%), Net Contents: 18 oz/ 532 ml per foam pu
Hazard: CGMP Deviations
April 21, 2021DrugsFDA
Spartan Chemical Co Inc recalls Lite'n Foamy E2 Sanitizing Handwash (Benzalkonium Chloride, 0.13%), Net Contents: 1 US Gallon/ 3.79 Liters per gallon co
Hazard: CGMP Deviations
April 21, 2021DrugsFDA
Spartan Chemical Co Inc recalls Antiseptic Hand Cleaner (Chloroxylenol, 1.0%), Net Contents: 1 US Gallon/ 3.79 Liters per gallon container, For Institut
Hazard: CGMP Deviations
April 21, 2021DrugsFDA
Spartan Chemical Co Inc recalls foamyiQ Lemon Blossom Hand Sanitizer (benzalkonium chloride 0.1%), Net Contents: 42.27 oz/1250 ml per foam pump cartridg
Hazard: CGMP Deviations
April 21, 2021DrugsFDA
Spartan Chemical Co Inc recalls Lite'n Foamy Lemon Blossom Hand Sanitizer (benzalkonium chloride 0.1%), Net Contents: 18 oz/ 532 ml per foam pump contai
Hazard: Microbial Contamination of Non-Sterile Products; lot tested positive for Bulkholderia multivorans
April 21, 2021DrugsFDA
SUN PHARMACEUTICAL INDUSTRIES INC recalls Riomet (metformin hydrochloride oral solution) 500 mg/5 mL Cherry Flavor, 16 fl. oz., 473 mL bottles Rx Only, Manufactur
Hazard: Microbial Contamination of Non-Sterile Product
April 21, 2021DrugsFDA
Jubilant Cadista Pharmaceuticals, Inc. recalls Itraconazole Capsules, 100 mg, 30-count bottles, Rx only, Manufactured by: Jubilant Generics Ltd., Roorkee - 247661, Ind
Hazard: Failed Dissolution Specifications
April 21, 2021DrugsFDA
Lupin Pharmaceuticals Inc. recalls Cefprozil for Oral Suspension USP, 250mg/5mL, packaged as a) 50 mL (when mixed) bottles (NDC 68180-402-01); b) 75 mL (wh
Hazard: Superpotent Drug
April 21, 2021DrugsFDA
Teligent Pharma, Inc. recalls Lidocaine Ointment USP, 5%, NET WT 35.44 g (1 1/4 Oz) tube, Rx Only, Teligent Pharma Inc., Buena, New Jersey, 08310, NDC
Hazard: Failed Stability Specifications: product did not meet viscosity results.
April 21, 2021DrugsFDA
Asclemed USA Inc. dba Enovachem Pharmaceuticals recalls Distributed by: DocRx, Methylprednisolone Tablets, USP 4 mg, Rx, 21 Count Blister, NDC: 69306-004-21, Relabeled by: Enov
Hazard: Labeling: Illegible label: Manufacturer received complaint of mis-alignment print of the printed dosing instructions on the blister card.
April 21, 2021DrugsFDA
Macleods Pharma Usa Inc recalls Candesartan Cilexetil Tablets, USP, 4 mg, 30-count bottles, Rx only, Manufactured for: Macleods Pharma USA, Inc., Plains
Hazard: Failed Impurities/Degradation Specifications
April 14, 2021DrugsFDA
X-Gen Pharmaceuticals Inc. recalls Neomycin Sulfate Tablets, USP 500mg, Rx Only, 10x10 Unit dose 100 Tablets, Manufactured for: X-GEN Phamaceuticals, Inc.
Hazard: Failed Stability Specifications: Out of Specification (OOS) result reported for microbiological assay
April 14, 2021DrugsFDA
Cosette Pharmaceuticals, Inc. recalls Mometasone Furoate Topical Solution, USP, 0.1%, (Lotion), a) 30 mL (NDC 0713-0701-85) and b) 60 mL (NDC 0713-0701-53), R
Hazard: CGMP Deviaitons
April 14, 2021DrugsFDA
Alembic Pharmaceuticals Limited recalls Telmisartan Tablets, USP 20 mg, 30-count bottles, Rx only, Manufactured by: Alembic Pharmaceuticals Limited (Formulation
Hazard: Labeling: Label-mixup
April 14, 2021DrugsFDA
SUN PHARMACEUTICAL INDUSTRIES INC recalls Metformin HCl Extended-Release Tablets, USP, 500 mg, Rx Only, 500-count bottle, Rx only, Distributed by: Sun Pharmaceuti
Hazard: Failed Moisture Limits: Out of specification for water content
April 14, 2021DrugsFDA
Apotex Corp. recalls Guanfacine Extended-Release Tablets 2 mg,100-count bottles, Rx Only, Manufactured by: Apotex Inc. Toronto, Ontario Canad
Hazard: Cross Contamination with Other Product: Product is being recalled due to Trace Amounts of Quetiapine Fumarate
April 14, 2021DrugsFDA
Washington Homeopathic Products, Inc. recalls LCL-2-0191, 5 gallon carboys, Rx only, Manufactured for: LaCore Labs, LLC, by: Washington Homeopathic Products, Inc.260
Hazard: An error occurred where the product was manufactured with Potassium Chloride instead of Potassium Phosphate.
April 14, 2021DrugsFDA
Washington Homeopathic Products, Inc. recalls Sp-4, 100 mL solution bottles, Rx only, Washington Homeopathic Products, Inc.260 J R Hawvermale Way Berkeley Springs We
Hazard: An error occurred where the product was manufactured with Potassium Chloride instead of Potassium Phosphate.
April 14, 2021DrugsFDA
Washington Homeopathic Products, Inc. recalls Macula Pellets Homeopathic Medicine, 1 Oz bottles, Rx only, Manufactured for: Natural Ophthalmics Inc. PO Box 1510 Dillo
Hazard: An error occurred where the product was manufactured with Potassium Chloride instead of Potassium Phosphate.
April 14, 2021DrugsFDA
SUN PHARMACEUTICAL INDUSTRIES INC recalls Ganirelix Acetate Injection, 250 mcg/0.5 mL, Sterile Prefilled Syringe, Rx only, Distributor: Ferring Pharmaceuticals, I
Hazard: Failed Impurities/Degradation Specifications
April 14, 2021DrugsFDA
Kimberly-Clark Corporation recalls Scott¿ Moisturizing Foam Hand Sanitizer, 1.2 Liters (40.5 fl oz), Distributed in the U.S. by Kimberly-Clark Global Sales
Hazard: Labeling; Label Mix-up; some bottles containing Foam Skin Cleanser soap are incorrectly labeled as Moisturizing Foam Hand Sanitizer
April 7, 2021DrugsFDA
Ferring Pharmaceuticals Inc recalls ZOMA-Jet 10 Demonstration Kit, Needle-free delivery device for use with ZOMACTON (somatropin) for injection 10 mg vial,
Hazard: Defective Delivery System: customer complaints concerning the injector pen breaking apart and disintegrating into pieces.
April 7, 2021DrugsFDA
Ferring Pharmaceuticals Inc recalls ZOMA-Jet 5 Demonstration Kit, Needle-free delivery device for use with ZOMACTON (somatropin) for injection 5mg vial, Rx
Hazard: Defective Delivery System: customer complaints concerning the injector pen breaking apart and disintegrating into pieces.
April 7, 2021DrugsFDA
Zydus Pharmaceuticals (USA) Inc recalls Acyclovir Sodium Injection 500mg/10mL (50mg/mL) vial NDC 68382-048-01, For Intravenous Infusion Only MUST BE DILUTED PRI
Hazard: Crystallization: customer complaints for crystallization in finished product.
April 7, 2021DrugsFDA
Zydus Pharmaceuticals (USA) Inc recalls Acyclovir Sodium Injection 1000mg/20mL (50mg/mL) vial NDC 68382-049-01, For Intravenous Infusion Only MUST BE DILUTED PR
Hazard: Crystallization: customer complaints for crystallization in finished product.
April 7, 2021DrugsFDA
Cardinal Health Inc. recalls Tremfya (guselkumab) Injection, 100 mg/mL, one single-dose prefilled syringe per carton, Rx only, Manufactured by: Janss
Hazard: Temperature Abuse
March 31, 2021DrugsFDA
ICU Medical Inc recalls 0.9% SODIUM CHLORIDE Irrigation, USP 1000 mL Semi-Rigid Bottle, Rx only, Manufactured for ICU Medical, Inc., Lake Forest
Hazard: Presence of particulate matter.one confirmed customer report of particulate matter within two semi-rigid bottles identified prior to use
March 31, 2021DrugsFDA
Golden State Medical Supply Inc. recalls Omeprazole Delayed Release Capsules, USP, 20 mg, 1000-count bottles, Rx only, Packaged by GSMS Incorporated, Camarillo,
Hazard: Failed Impurities/Degradation Specifications: Out of Specification results obtained for unknown impurities during stability testing by manufacturer
March 31, 2021DrugsFDA
Adams.Secret.co recalls Adam's Secret Extra Strength 3000, 840 mg, 10 count blister packs, Distributed by AS Inc., Made in USA, UPC 6 09728 434
Hazard: Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil and sildenafil.