FDA
Clonidine Transdermal System, USP, 0.2 mg/day, supplied in cartons of 4 Systems and 4 Adh… Recalled: CGMP Deviations: use of an unapproved raw material
CGMP Deviations: use of an unapproved raw material
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1,498 recalls found — page 40 of 63.
- FDA
Clonidine Transdermal System, USP, 0.1 mg/day, supplied in cartons of 4 Systems and 4 Adh… Recalled: CGMP Deviations: use of an unapproved raw material
CGMP Deviations: use of an unapproved raw material
- FDA
Clonidine Transdermal System, USP, 0.3 mg/day, supplied in cartons of 4 Systems and 4 Adh… Recalled: CGMP Deviations: use of an unapproved raw material
CGMP Deviations: use of an unapproved raw material
- FDA
traMADol Hydrochloride Tablets, USP, 50 mg, 500-count bottles, Rx only, Manufactured by:… Recalled: Failed Impurities/Degradation Specifications: N-nitroso-desmethyl-tramadol impurity (NDSR…
Failed Impurities/Degradation Specifications: N-nitroso-desmethyl-tramadol impurity (NDSRI) was found out of the specification at 24-month stability interval during Long term stability (25¿C/60%RH).
- FDA
Remedy Gel, hydrocortisone 1%, 30 mL/ 1 fl oz per bottle, Distributed By: glo Skin Beauty… Recalled: Subpotent Drug
Subpotent Drug
- FDA
Essential Calming Skin Gel, hydrocortisone 1%, 120mL/4oz net wt. (113g) per jar, Distribu… Recalled: Subpotent Drug
Subpotent Drug
- FDA
Skin Rehab, Calming Skin Gel, Hydrocortisone Balm, hydrocortisone 1%, .53oz net wt. (15.3… Recalled: Subpotent Drug
Subpotent Drug
- FDA
Magnesium Sulfate in Water for Injection, 4g/100 mL (40mg/mL) IV bag, further packaged in… Recalled: Product mix up: a foil pouch labeled "Magnesium Sulfate in Water for Injection, 4 g/100 m…
Product mix up: a foil pouch labeled "Magnesium Sulfate in Water for Injection, 4 g/100 mL" actually contained an IV bag of Tranexamic Acid instead.
- FDA
Albuterol Sulfate Inhalation Solution, 0.5%, 25 mg/5 mL (5 mg/mL*), 30x5 mL Sterile Unit-… Recalled: Labelling: Illegible label
Labelling: Illegible label
- FDA
Xanax XR, alprazolam, extended-release tablets, 3 mg, 60 Tablets bottles, Rx only, Distri… Recalled: Failed Dissolution Specifications
Failed Dissolution Specifications
- FDA
Octreotide Acetate for Injectable Suspension, for gluteal intramuscular use, 20 mg, Singl… Recalled: Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U…
Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the contract manufacturer.
- FDA
Octreotide Acetate for Injectable Suspension, for gluteal intramuscular use, 10 mg, Singl… Recalled: Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U…
Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the contract manufacturer.
- FDA
Octreotide Acetate for Injectable Suspension, for gluteal intramuscular use, 30 mg, Singl… Recalled: Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U…
Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the contract manufacturer.
- FDA
CUROSURF (poractant alfa), 240 mg, Intratracheal Suspension, 3L Single-dose-Vial, Rx only… Recalled: Lack of Assurance of Sterility
Lack of Assurance of Sterility
- FDA
Cinacalcet Hydrochloride Tablets, 30 mg, 30 Tablets per bottle, Rx Only, Manufactured by:… Recalled: CGMP Deviations; presence N-Nitroso Cinacalcet above the acceptable daily intake limit
CGMP Deviations; presence N-Nitroso Cinacalcet above the acceptable daily intake limit
- FDA
Cinacalcet Hydrochloride Tablets, 90 mg, 30 Tablets per bottle, Rx Only, Manufactured by:… Recalled: CGMP Deviations; presence N-Nitroso Cinacalcet above the acceptable daily intake limit
CGMP Deviations; presence N-Nitroso Cinacalcet above the acceptable daily intake limit
- FDA
Cinacalcet Hydrochloride Tablets, 60 mg, 30 Tablets per bottle, Rx Only, Manufactured by:… Recalled: CGMP Deviations; presence N-Nitroso Cinacalcet above the acceptable daily intake limit
CGMP Deviations; presence N-Nitroso Cinacalcet above the acceptable daily intake limit
- FDA
Meclizine Hydrochloride Tablets, USP 12.5 mg, (a) 50 Tablets [5 x 10] (NDC 60687-775-65)… Recalled: Failed tablet specifications.
Failed tablet specifications.
- FDA
Blue Bull Extreme Male Enhancement Supplement, total of 15 pouches per box, Net Wt 15 G e… Recalled: FDA analysis revealed the presence of undeclared sildenafil
FDA analysis revealed the presence of undeclared sildenafil
- FDA
Red Bull Extreme Male Enhancement Supplement, total of 15 pouches per box, Net Wt 15 G ea… Recalled: FDA analysis revealed the presence of undeclared sildenafil
FDA analysis revealed the presence of undeclared sildenafil
- FDA
Buprenorphine Hydrochloride, Injection, 0.3mg/mL, 5x1 mL Single Dose Vials, Rx only, Manu… Recalled: Crystallization; identified as Buprenorphine free base
Crystallization; identified as Buprenorphine free base
- FDA
Lanreotide Injection, 120 mg/0.5 mL, Box contains 1 Pre-filled syringe, Single dose only,… Recalled: Lack of Assurance of Sterility: Due to an FDA observation at the contract manufacturing s…
Lack of Assurance of Sterility: Due to an FDA observation at the contract manufacturing site for deficiencies in their visual inspection procedure.
- FDA
Lanreotide Injection, 120 mg*/0.5 mL, Box contains 1 Pre-filled syringe and 1 safety need… Recalled: Lack of Assurance of Sterility: Due to an FDA observation at the contract manufacturing s…
Lack of Assurance of Sterility: Due to an FDA observation at the contract manufacturing site for deficiencies in their visual inspection procedure.
- CPSC
17 Stories Furniture 14-Drawer Dressers Recalled Due to Risk of Serious Injury or Death from Tip-Over and Entrapment Hazards; Violates Mandatory Standard for Clothing Storage Units; Imported by Hong Kong Baojia International
The recalled dressers are unstable if they are not anchored to the wall, posing tip-over and entrapment hazards that can result in risks of serious injuries or death to children. The dressers violate the mandatory standard as required by the STURDY Act.