Chemical Contamination and CGMP Deviations: trace amounts of methanol found in one of the components during the manufacturing process.
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Drugs Recalls
Prescription and over-the-counter medications
17,685 Total Recalls
Class I - Dangerous
Boxes mislabeled to read "Decongestant Free", but the product contains Phenylephrine HCI 5mg
Rifampin Capsules, USP, 150 mg, 30-count bottle, Rx only, Manufactured by Patheon Pharmaceuticals Inc., OH, Packaged by GSMS, Incorporated, CA, NDC 51407-322-30
Golden State Medical Supply
Class I - Dangerous
Failed impurities/degradation specifications: Finished product exceeds the 5 ppm interim limit for 1-Methyl-4-Nitrosopoperazine (MNP).
Flunisolide Nasal Solution, USP 0.025%, 25 mL bottles, Rx only, Manufactured for: Ingenus Pharmaceuticals, LLC Orlando, FL 32839-6408; NDC 50742-317-25 UPC 3 50742 31725 7
Ingenus Pharmaceuticals
Class I - Dangerous
Out of specification for related substances (impurities).
Class I - Dangerous
Presence of Particulate Matter: Customer complaint for a dark red, brown and black particulate floating inside vial.
0.9% Sodium Chloride Injection, USP, Each 100 mL contains: SODIUM CHLORIDE, USP - 900 mg, WATER FOR INJECTION, USP - qs, 1000mL Bag, 12 PK, Rx Only, Fresenius Medical Care North America, Waltham, MA 02451, NDC 49230-300-10
Fresenius Medical Care Holdings
Class I - Dangerous
Lack of Assurance of Sterility: Leakage of 0.9% Sodium Chloride for Injection, 1L, 12pk Saline Solution.
Class I - Dangerous
Failed impurities/degradation specifications: Finished product exceeds the 5 ppm interim limit for 1-Methyl-4-Nitrosopoperazine (MNP).
Skincell Mole & Skin Corrector Serum, 1 fl. oz./30 mL jars, Distributed By: Justified Laboratoires, Arlington, TX 76011 USA UPC 8 10077 53220 1
Justified Laboratories
Class I - Dangerous
Marketed Without An Approved NDA/ANDA; Unapproved new drug
Skincell Mole & Skin Corrector Serum, 1 fl. oz./30 mL jars, Distributed By: Justified Laboratoires, Arlington, TX 76011 USA UPC 8 10077 53221 8
Justified Laboratories
Class I - Dangerous
Marketed Without An Approved NDA/ANDA; Unapproved new drug
Class I - Dangerous
Presence of Particulate Matter: Piece of metal found in a vial
Antica Farmacista Hand Sanitizer Ocean Citron (ethyl alcohol, denatured 65%) packaged in 473 mL/16 fl. oz. bottles, Dist. By Antica Farmacista Seattle, WA 98122 UPC 8 47005 00450 9
Salon Technologies International
Class I - Dangerous
Chemical Contamination: product found to contain benzene
Lack of Assurance of Sterility: environmental monitoring failure.
Sanitizing Hand Spray 80% (alcohol 80% v/v) Packaged in 2 FL OZ (60 mL) bottles, Salon Technologies International 8810 Commodity Circle STE 22-23, Orlando, FL 32819, UPC 6 96952 12904 5
Salon Technologies International
Class I - Dangerous
GMP Deviations: FDA analysis found product to contain acetaldehyde and acetal above specification limits.
Phytonadione Injectable Emulsion USP, 10 mg/mL, 25x 1 mL single dose ampules per carton, Rx only, Distributed by: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, NDC 43598-405-16
Dr. Reddy's Laboratories
Class I - Dangerous
Failed Stability Specifications: Out of specification results reported at 12-month stability testing for aluminum content.
Antibacterial Foaming Wash with Hydria Moisturizing Formula, Cucumber-Melon Scent, 1250 mL (42 fl oz.), Manufactured for: Triple S, 800-323-2251, Made in USA, NDC 11429-1010-8
Woodbine Products Co
Class I - Dangerous
Labeling: Not Elsewhere Classified - Incorrect label-incorrect scent listed on label.
Class I - Dangerous
Presence of Particulate Matter: A complaint was received for the presence of a hair in one vial.
Esomeprazole Magnesium Delayed-Release Capsules, USP 20mg, Rx Only, 90 Capsules per bottle, Manufactured by: Ohm Laboratories Inc. New Brunswick, NJ 08901, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, NDC 63304-734-90.
SUN PHARMACEUTICAL INDUSTRIES
Class I - Dangerous
Superpotent Drug: Out of specification for assay at the 12-month timepoint.
Class I - Dangerous
Presence of Particulate Matter: A complaint was received for the presence of a single strand of hair in one vial.
Class I - Dangerous
Incorrect Product Formulation: Oxytocin 30 units was added to an IV bag of 0.45% Sodium Chloride (500mL) instead of 0.9% Sodium Chloride (500mL).
Esomeprazole Magnesium Delayed-Release Capsules, USP, 40mg, Rx Only, 90 Capsules per bottle, Manufactured by: Ohm Laboratories Inc. New Brunswick, NJ 08901, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, NDC 63304-735-90.
SUN PHARMACEUTICAL INDUSTRIES
Class I - Dangerous
Superpotent Drug: Out of specification for assay at the 12-month timepoint.