Class I - Dangerous
Lack of Assurance of Sterility
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Drugs Recalls
Prescription and over-the-counter medications
17,302 Total Recalls
Class I - Dangerous
Lack of Assurance of Sterility
Class I - Dangerous
Lack of Assurance of Sterility
Class I - Dangerous
Failed Impurities/Degradation Specifications: Out of specification for organic impurities
Neptune's Fix, Tianeptine Elixir, Fast Acting, 0.338 fl.oz. (10 mL) bottle, Distributed By Superchill Products, 827 6th Avenue, New York, New York 10001.
Super Chill Products
Class I - Dangerous
Marketed without an approved NDA/ANDA: Product contains tianeptine, a substance not FDA-approved for any medical use in the United States.
Class I - Dangerous
Failed Impurities/Degradation Specifications: Out of specification for organic impurities
Class I - Dangerous
Cross Contamination with Other Products:(mycophenolate mofetil).
Infumorph (Preservative-free Morphine Sulfate Sterile Solution), 20 mL ampul, Rx only, Manufactured by Hikma Berkeley Heights, NJ 07922, NDC 0641-6039-01
Hikma Pharmaceuticals USA
Class I - Dangerous
The filter included in the carton has an expiration date that has expired prior to the expiration date of the actual product lot.
Class I - Dangerous
Lack of Assurance of Sterility: Out of specification for volume and compromised container closure.
Class I - Dangerous
Stability testing failures for one or two of the four active pharmaceutical ingredients among the finished drug products, i.e., Phenylephrine HCL, and/or Chlorpheniramine Maleate.
Bicillin L-A (Penicillin G Benzathine) 1.2, MMU / 2 mL Injection Prefilled Syringe 2 mL, Rx only, Mfg: Pfizer Pharmaceuticals, NDC 60793-0701-10
Mckesson Medical-Surgical Inc. Corporate Office
Class I - Dangerous
cGMP Deviations: Products were stored outside the drug label specifications.
Class I - Dangerous
Lack of assurance of sterility: pinholes, within the blue label characters on the EXCEL bag, specifically within the dotted characters on the label, resulting in leaks.
Class I - Dangerous
Failed Stability Specification: Water determination was found not complying with specification.
Febuxostat Tablets 80mg, RX Only, 30 Tablets per bottle, NorthStarx, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Sun Pharmaceutical Industries Limited Survey No. 259/15, Dadra-396 191, (U.T. of D & NH), India, NDC 16714-060-01.
SUN PHARMACEUTICAL INDUSTRIES
Class I - Dangerous
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Rocuronium Bromide Injection, Preservative Free, 10 mg / mL, Multiple-Dose Vial 10 mL, Rx only, Mfg: Auromedics Pharma LLC, NDC 55150-226-10
Mckesson Medical-Surgical Inc. Corporate Office
Class I - Dangerous
cGMP Deviations: Products were stored outside the drug label specifications.
TRP Natural Eyes Floaters Relief, Sterile Eye Drops, 0.33 FL OZ (10 mL), Manufactured for TRP Company, Inc, 1575 Delucchi Lane, Suite # 208, Reno, NV, NDC # 17312-098-15.
Optikem International
Class I - Dangerous
Lack of Assurance of Sterility
Febuxostat Tablets 40mg, RX Only, 30 Tablets per bottle, NorthStarx, Manufactured for: Northstar Rx LLC., Memphis, TN 38141 , Manufactured by: Sun Pharmaceutical Industries Limited Survey No. 259/15, Dadra-396 191, (U.T. of D & NH), India, NDC 16714-059-01.
SUN PHARMACEUTICAL INDUSTRIES
Class I - Dangerous
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
TRP Natural Eyes Allergy Eyes Relief, Sterile Eye Drops, Homeopathic 0.33 FL OZ (10mL), Manufactured for TRP Company, Inc, 1575 Delucchi Lane, Suite # 208, Reno, NV, NDC # 17312-032-15.
Optikem International
Class I - Dangerous
Lack of Assurance of Sterility
Class I - Dangerous
Stability testing failures for one or two of the four active pharmaceutical ingredients among the finished drug products, i.e., Phenylephrine HCL, and/or Chlorpheniramine Maleate.
Infuvite Adult Multiple vitamins injection, single-dose vial 5mL, Rx only, MFG: Baxter Healthcare Corp., NDC 54643-5649-01
Mckesson Medical-Surgical Inc. Corporate Office
Class I - Dangerous
cGMP Deviations: Products were stored outside the drug label specifications.