Class I - Dangerous
Lack of Assurance of Sterility
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Prescription Drugs
💊 Drugs • 12,141 recalls
Class I - Dangerous
Failed Impurities/Degradation Specifications: Out of specification for organic impurities
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.
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.
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.
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.
Class I - Dangerous
Failed Stability Specifications: Out of specification for blend uniformity.
Clindamycin Phosphate, Topical Solution USP, 1%, 60 mL, Rx Only, Manufactured for and Distributed by: Marlex Pharmaceuticals, Inc., New Castle, DE 19720, NDC 10135-0691-61
Contract Pharmaceuticals Limited Canada
Class I - Dangerous
Defective Container: Out of specification for weight due to a slow leakage at the 12-month stability timepoint.
Class I - Dangerous
Failed Dissolution Specifications
Class I - Dangerous
Failed Dissolution Specifications: results slightly under spec at at 9-months.
Mesalamine Extended-Release Capsules, USP 500mg, Rx Only, 120 Capsules per bottle, Manufactured by: Sun Pharmaceutical Industries Limited, Mohali, INDIA, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, NDC 63304-089-13.
SUN PHARMACEUTICAL INDUSTRIES
Class I - Dangerous
Failed Dissolution Specifications: Out of specification for dissolution.
Fluticasone Propionate Nasal Spray USP, 50 mcg per spray, 120 metered sprays, 16 g net fill, Rx only, Manufactured by: Apotek Inc., Toronto, Ontario, Cananda, Marketed by: GSMS Incorporated, Camarillo, CA, NDC 60429-195-15
Golden State Medical Supply
Class I - Dangerous
CGMP Deviations:Suspected potential presence of Burkholderia cepacia complex
Moxifloxacin 5mg/ml, 1 ml in a Single- Dose Vial, Rx Only, Leiters 13796 Compark Blvd, Englewood, CO 80112, NDC 71449-097-42
Denver Solutions, LLC
Class I - Dangerous
Presence of Particulate Matter: glass vials from the manufacturer showed signs of glass delamination.