SUN PHARMACEUTICAL INDUSTRIES INC recalls
34 recalls on record · FDA
Every recall we have on record for SUN PHARMACEUTICAL INDUSTRIES INC, compiled from federal safety data. Check the hazard, the remedy, and how serious each one is, and always confirm on the official notice.
Fluocinonide, USP, 0.05% Cream, 30g tube, Rx only, Mfd by: Taro Pharmaceuticals Inc.,…
Failed Viscosity Specifications: Out of Specification results, above the specification limit, in viscosity, noted during stability testing.
Fluocinonide, USP, 0.05% Cream, 60g tube, Rx only, Mfd by: Taro Pharmaceuticals Inc.,…
Failed Viscosity Specifications: Out of Specification results, above the specification limit, in viscosity, noted during stability testing.
Diclofenac Sodium, Topical Gel, 3%, 100 g tube, Rx only, Mfd. by: Taro Pharmaceuticals…
Failed Viscosity Specifications: Out of Specification (OOS) [slightly lower than the limit] result in viscosity for Diclofenac Sodium Gel, 3%.
Fluocinolone Acetonide Solution Topical Solution USP, 0.01%, 60-mL bottles, Rx only,…
Failed Impurities/Degradation Specifications: Out of specification result was obtained for the known impurity D.
Lisdexamfetamine Dimesylate Capsules, 60 mg, CII, 100-count bottle, Rx only, Manufactured…
Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 12-month long term stability station (25¿C, 60%RH) for Lisdexamfetamine dimesylate capsules.
Lisdexamfetamine Dimesylate Capsules, 50 mg, CII, 100-count bottle, Rx only, Manufactured…
Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 12-month long term stability station (25¿C, 60%RH) for Lisdexamfetamine dimesylate capsules.
Spironolactone Tablets, USP, 25 mg, 100-count bottle, Rx only, Mfg. by: Frontida…
Presence of foreign substance: identified as aluminum.
Gabapentin Capsules, USP 400 mg, Rx Only, Packaged in a) 500-count bottles, NDC…
Cross Contamination
Xelpros (latanoprost ophthalmic emulsion) 0.005%, 125mcg/2.5mL, 2.5 mL bottle, Rx only,…
Failed Release Testing: Out of specification for particulate matter test.
Amphotericin B Liposome for Injection, 50mg vials, Rx only, Distributed by: Sun…
Out of specification for assay
Febuxostat Tablets 80mg, RX Only, 30 Tablets per bottle, NorthStarx, Manufactured for:…
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Mesalamine Extended-Release Capsules, USP 500mg, Rx Only, 120 Capsules per bottle,…
Failed Dissolution Specifications: Out of specification for dissolution.
Lurasidone Hydrochloride Tablets 60mg, Rx Only, 30 Tablets per bottle, Distributed by: …
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Zolpidem Tartrate Extended-Release Tablets, USP 12.5mg, Rx Only, 100 Tablets per bottle,…
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Mesalamine Delayed-Release Tablets, USP 1.2 g per tablet, Rx Only, 120 Tablets per…
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Cinacalcet Tablets 60mg, Rx Only, 30 Tablets per bottle, Distributed by: Sun…
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Lurasidone Hydrochloride Tablets 120mg, Rx Only, 30 Tablets per bottle, Distributed by: …
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Liothyronine Sodium Tablets, USP 5 mcg, 100-count bottle, Rx Only, Distributed by: Sun…
Failed Impurities/Degradation Specifications
Dofetilide Capsules 500 mcg (0.5mg), 60-count bottle, Rx Only, Manufactured by Sun…
Out of Specification result observed in content uniformity testing
Methylphenidate Hydrochloride Tablets, USP 20mg, Rx Only, 100 Tablets per bottle,…
Presence of Foreign Substance: Metal embedded in a tablet.
Tiagabine Hydrochloride Tablets, 2 mg, 30-count bottle, Distributed by Sun Pharmaceutical…
Failed Impurities: Out of Specification (OOS) result observed during Related Substances testing
Buprenorphine Sublingual Tablets, 8 mg, 30 count-bottles, Rx only, Manufactured by: Sun…
CGMP Deviations
Oxcarbazepine Tablets 600mg, packaged in a) 100- count bottles (NDC 62756-185-88), b)…
Presence of foreign substance
Esomeprazole Magnesium Delayed-Release Capsules, USP 20mg, Rx Only, 90 Capsules per…
Superpotent Drug: Out of specification for assay at the 12-month timepoint.
Esomeprazole Magnesium Delayed-Release Capsules, USP, 40mg, Rx Only, 90 Capsules per…
Superpotent Drug: Out of specification for assay at the 12-month timepoint.
Testosterone Cypionate Injection, USP, 200mg/mL, CIII, Rx only, 1mL Single-dose vial,…
cGMP - Water leakage
Testosterone Cypionate Injection, USP, 200mg/ml, Rx Only, One Single-dose vial,…
CGMP Deviations: Manufacturing deviations were reported due to an abnormal appearance on parts of machinery.
Testosterone Cypionate Injection, USP, 200 mg/mL, 1 mL Single-dose vial per carton, Rx…
CGMP Deviations: lots made with same active pharmaceutical ingredient (API) as lots that were rejected due to manufacturing issues that could cause the product to be out of specification for impurities.
Testosterone Cypionate Injection, USP, 200 mg/mL, 1 mL Single-dose vial per carton, Rx…
Lack of Assurance of Sterility: Manufacturing deviation which was reported due to a microbial excursion
medroxyPROGESTERone Acetate Injectable Suspension, USP, 1 mL Prefilled Syringe, 150…
Lack of assurance of sterility
medroxyPROGESTERone Acetate Injectable Suspension, USP, 25 x 1 mL Single-Dose Vial, 150…
Lack of assurance of sterility
medroxyPROGESTERone Acetate Injectable Suspension, USP, 1 mL Prefilled Syringe, 150…
Lack of assurance of sterility
medroxyPROGESTERone Acetate Injectable Suspension, USP, 1 mL Single-Dose Vial, 150 mg/mL,…
Lack of assurance of sterility
Chlorthalidone Tablets USP 25 mg, Rx Only, 100 Tablets, Sun Pharma, Mfg. by: Fontida Bio…
Foreign Matter identified as stainless steel microscopic wear particles mixed with punch lubricant oil and silicone particles from the dust cup