FDA Recalls
Page 37 of 39 · 1,907 total recalls
Recalls — Page 37
Nivagen, Zinc Oxide Ointment USP, Zinc Oxide 20 %, Net Wt
cGMP deviations
Nivagen Pharmaceuticals, Zinc Oxide Ointment USP, Zinc Oxide 20% Skin Protectant, Net Wt
cGMP deviations
Phytonadione Injectable Emulsion, USP 10mg/mL, 10x1 mL Single-Dose Vial/carton, Rx Only, Mfd
Failed Stability Specifications: Observed OOS results: eg results for colour index
2% Xylocaine DENTAL with Epinephrine 1:100
Defective container: cracked/broken cartridges
3% Polocaine DENTAL
Defective container: cracked/broken cartridges
Benco dental Graham CHEMICAL CO
Defective container: cracked/broken cartridges
darby dental supply
Defective container: cracked/broken cartridges
Lidocaine HCI 2% and Epinephrine 1:100
Defective container: cracked/broken cartridges
POTASSIUM CHLORIDE Inj
Labeling: Label Error on Declared Strength-The overwrap label may incorrectly identify the product as POTASSIUM...
POTASSIUM CHLORIDE Inj
Labeling: Label Error on Declared Strength-The overwrap label may incorrectly identify the product as POTASSIUM...
Agebox iKids-Growth (Day Formula) capsules
Marketed Without an Approved NDA/ANDA: presence of undeclared ibutamoren
Agebox iKids-Growth (Night Formula)
Marketed Without an Approved NDA/ANDA: presence of undeclared ibutamoren
Lisdexamfetamine Dimesylate Capsules
Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at...
Multivitamin with Fluoride Chewable Tablets Grape Flavor Rx NDC 75826-169-10 0.25 mg 100 TABLETS UPC 3 15826 16910 2
Subpotent. During an FDA inspection it was discovered that the product was subpotent for Vitamin D.
Lanthanum Carbonate chewable tablets
Failed stability specifications: Out of specification for hardness test
Lanthanum Carbonate chewable tablets
Failed stability specifications: Out of specification for hardness test
Bromocriptine Mesylate Capsules, USP, 5 mg, 30 Capsules per bottle, Rx Only
Failed Impurities/Degradation Specifications: Out of Specification (OOS) result reported for 2- Bromoergine impurity...
clomiPRAMINE Hydrochloride
cGMP deviations: an observed Out of Specification of Nitrosamine Drug Substance-Related Impurities (NDSRIs),...
clomiPRAMINE Hydrochloride
cGMP deviations: an observed Out of Specification of Nitrosamine Drug Substance-Related Impurities (NDSRIs),...
clomiPRAMINE Hydrochloride
cGMP deviations: an observed Out of Specification of Nitrosamine Drug Substance-Related Impurities (NDSRIs),...
SILINTAN 25/pills, packaged in a 25-count bottle, Shanghai Chinese Medical Works, Shanghai, China
Marketed Without an Approved NDA/ANDA: FDA analysis revealed the presence of undeclared meloxicam.
NIACIN Extended-Release Tablets
Failed Dissolution Specifications
Acetaminophen 500mg Caffeine 65mg caplets
Labeling: Label Mix-up. This issue affects the outer box labeling only. The box incorrectly states the ingredients...
Testosterone 50MG
CGMP Deviations: Potential presence of metal particulate matter
Testosterone 62.5 MG
CGMP Deviations: Potential presence of metal particulate matter
Testosterone / Triamcinolone Acetonide 25MG/5MCG
CGMP Deviations: Potential presence of metal particulate matter
Testosterone / Triamcinolone Acetonide Pellet (100MG/20MCG)
CGMP Deviations: Potential presence of metal particulate matter
Amoxicillin and Clavulanate Potassium for Oral Suspension USP
Subpotent drug; Clavulanate Potassium component
Fesoterodine Fumarate
Failed Impurities/Degradation Specifications: Due to levels of 'Diester Impurity' exceeding the specification limit.