Class I - Dangerous
Marketed without an approved NDA/ANDA: Product found to be tainted with undeclared dexamethasone and chlorpheniramine.
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Drugs Recalls
Prescription and over-the-counter medications
17,302 Total Recalls
Gold Hard Steel Plus Liquid, 2 FL OZ bottles, UPC 787188873199
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
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.
Ryaltris (olopatadine hydrochloride and mometasone fluorate) Nasal Spray, 665 mcg/25 mcg per spray, 240 Metered Sprays/bottle, 29 g net fill weight, Distr. by Hikma Specialty USA Inc., Columbus, OH 43328, hikma, Glenmark Specialty SA. NDC 59467-700-27.
Glenmark Pharmaceuticals Inc., USA
Class I - Dangerous
Defective Delivery System: The dip tube is clogged causing the spray not to work.
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
EnviroClean Hand Sanitizer Gel (isopropyl alcohol 70% v/v), 473 mL (16 fl. oz.) bottles, EnviroServe Chemicals Inc., 603 South Wilson Avenue, Dunn NC, 28334, NDC 76563-3010-1
EnviroServe Chemicals
Class I - Dangerous
CGMP deviations
Class I - Dangerous
Lack of Assurance of Sterility: The impacted lots may contain a breach in the tube seal.
Marketed without an approved NDA/ANDA: FDA analysis found product to be tainted with undeclared acetaminophen, diclofenac, and phenylbutazone.
Class I - Dangerous
Microbial Contamination of Non-Sterile Product
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.
Class I - Dangerous
Lack of Assurance of Sterility: The impacted lots may contain a breach in the tube seal.
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
Microbial contamination of non-sterile Products -