Phenylephrine HCl 0.9% Sodium Chloride Injection USP, 20 mg per 250 mL, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC 71506-002-58
Fresenius Kabi Compounding
Class I - Dangerous
CGMP violations
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Prescription Drugs
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Phenylephrine HCl 0.9% Sodium Chloride Injection USP, 10 mg per 250 mL, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC 71506-029-58
Fresenius Kabi Compounding
Class I - Dangerous
cGMP violations
Class I - Dangerous
Microbial Contamination of a Non-sterile Product: The product was found to be contaminated with Cohnella bacteria.
Class I - Dangerous
Failed Impurities/Degradation Specifications.
Dapsone Gel 7.5%, 60 gram pump, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Viona Pharmaceuticals Inc., Cranford, NJ 07016, NDC 72578-094-02.
VIONA PHARMACEUTICALS
Class I - Dangerous
Crystallization
Duloxetine Delayed-Release Capsules, USP, 20mg, Rx Only, 500-count bottles, Mfr. by: Towa Pharmaceutical Europe, S.L. Distributed by: BPI, NDC 51991-746-05.
Breckenridge Pharmaceutical
Class I - Dangerous
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Class I - Dangerous
Marketed without an approved NDA/ANDA: Product found to be tainted with undeclared dexamethasone and chlorpheniramine.
Class I - Dangerous
Presence of Particulate Matter: Presence of glass particle.
Class I - Dangerous
Presence of Foreign Tablets/Capsules: A Carbamazepine Extended-Release 400 mg tablet was found in a 1000-count bottle of Atorvastatin Calcium Tablets, USP 40 mg.
Pluvicto, 1000 MBq/mL (27 mCi/mL), lutetium, LU 177, vipivotide tetraxetan injection, Single-dose vial, Sterile, Manufacturer Advanced Accelerator Applications, 57 E. Willow Street, NJ 07041, Millburn USA. NDC 69488-0010-61
Advanced Accelerator Applications USA
Class I - Dangerous
CGMP deviations
Class I - Dangerous
Defective Container: Firm received complaints of broken tube at the seal.
Hard Steel Capsules packaged in 1 count blister packs in boxes of 10, 20 and 30, Manufactured in U.S.A.
Supercore Products Group
Class I - Dangerous
Marketed without an approved NDA/ANDA: FDA analysis found products to be tainted with undeclared acetaminophen and sildenafil.
Class I - Dangerous
Failed Dissolution Specifications
Marketed without an approved NDA/ANDA: FDA analysis found product to be tainted with undeclared acetaminophen, diclofenac, and phenylbutazone.
Class I - Dangerous
Lack of Assurance of Sterility
Proparacaine Hydrochloride Ophthalmic Solution, USP 0.5% (sterile), 15 mL bottle, Rx only, MFG: Bausch & Lomb, NDC 24208-730-06
Mckesson Medical-Surgical Inc. Corporate Office
Class I - Dangerous
Temperature abuse: Products exposed to improper temperature above drug label specifications.
Mupirocin Ointment, USP, 2%, 22 g, Rx only, Manufactured by: Glenmark Pharmaceuticals, Ltd., Colvale-Bardez, Goa 403513, India. Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ, 07430, NDC 68462-180-22.
Glenmark Pharmaceuticals Inc., USA
Class I - Dangerous
Subpotent Drug
AcetaZOLAMIDE Tablets, USP, 125 mg, 100 count bottled, Rx Only, Distributed by: Advagen Pharma Limited, Plainsboro, NJ, Manufactured by Rubicon Research Private Limited, Thane, India NDC 72888-047-01
Rubicon Research Private Limited
Class I - Dangerous
Discoloration
Class I - Dangerous
LABELING: LABEL MIX-UP.
Class I - Dangerous
Lack of Assurance of Sterility