Chemical Contamination and Subpotent Drug: FDA analysis found product to contain methanol and below label claim for ethanol.
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Drugs Recalls
Prescription and over-the-counter medications
17,302 Total Recalls
Azacitidine for Injection, 100 mg Lyophilized Powder, Single-Dose Vials, Rx Only, Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213 India. Manufactured for BluePoint Laboratories. NDC 68001-0313-56
Amerisource Health Services
Class I - Dangerous
Subpotent Drug
Avant Foaming Hand Sanitizer, ethanol 62%, a) 18 fl. oz. bottle (530 mL), b) 1000 mL (33.9 fl. oz.) pouch, c) 55 gallon drum, Fragrance Free, Manufactured for B4 Brands, Lisbon, Iowa 62253
Aire-Master of America
Class I - Dangerous
CGMP Deviations: product manufactured using deionized water from a system lacking appropriate microbial control post deionization.
Stage 2-Ophardt Foaming Hand Sanitizer, Fragrance-Free, 1000 mL (33.9 fl. oz.) per bottle, Manufactured for 2XL Corporation, 2 Gateway Ct, Ste A, Bolingbrook, IL 60440
Aire-Master of America
Class I - Dangerous
CGMP Deviations: product manufactured using deionized water from a system lacking appropriate microbial control post deionization.
Class I - Dangerous
Lack of Assurance of Sterility
Azacitidine for Injection 100mg/vial Lyophilized Powder, Rx Only, Mfd. in Romania By: Sindan Pharma SRL For BluePoint Laboratories, NDC 68001-313-56
Teva Pharmaceuticals USA
Class I - Dangerous
Subpotent Drug - Out of specification (OOS) result obtained during monitoring stability study for Assay. Results below specification.
Systane Zaditor, ketotifen fumarate ophthalmic solution 0.035%, Antihistamine eye drops, Eye Itch Relief, up to 12 Hours, Sterile, 30 day supply, 5mL (0.17 FL OZ) bottle per box, Alcon, NDC 0065-4011-05.
Mckesson Medical-Surgical Inc. Corporate Office
Class I - Dangerous
CGMP Deviations: products were stored outside the drug label specifications.
Pataday, Once Daily Relief, Olopatadine hydrochloride ophthalmic solution 0.2%, Antihistamine, Eye Allergy Itch Relief, Once Daily, Sterile, 2.5 mL (0.085 FL OZ) bottle per box, Alcon, NDC 0065-8150-01.
Mckesson Medical-Surgical Inc. Corporate Office
Class I - Dangerous
CGMP Deviations: products were stored outside the drug label specifications.
Miralax (Polyethylene Glycol 3350), Powder for Solution, Osmotic Laxative, 30 Once-Daily Doses, Net WT 17.9 OZ (510 g) bottle, Bayer Healthcare Pharmaceuticals, NDC 11523-7234-4.
Mckesson Medical-Surgical Inc. Corporate Office
Class I - Dangerous
CGMP Deviations: products were stored outside the drug label specifications.
Ativan Injection (lorazepam injection, USP), 2mg/mL, 1 mL vial, 25 vials per carton, RX Only, Manufactured by West-Ward Eatontown, NJ 07724, Carton NDC# 0641-6001-25, Vial NDC# 0641-6001-01
Hikma Pharmaceuticals USA
Class I - Dangerous
Failed Impurities/Degradation Specifications: Out-of-specification results observed for total related compounds during testing of retain samples.
Racepinephrine Inhalation Solution, USP 2.25%, Bronchodilator, For Oral Inhalation Only, Sulfite Free, Preservative Free, 30 x 0.5 mL Sterile Unit-of-Use Vials, each in a foil pouch, per carton, Nephron Pharmaceuticals Corporation, NDC 0487-5901-99.
Mckesson Medical-Surgical Inc. Corporate Office
Class I - Dangerous
CGMP Deviations: products were stored outside the drug label specifications.
GenTeal Tears, Lubricant Eye Ointment, Night-Time Ointment, Sterile, 3.5 gm (0.12 FL OZ) per box, Alcon, NDC 0065-0518-01.
Mckesson Medical-Surgical Inc. Corporate Office
Class I - Dangerous
CGMP Deviations: products were stored outside the drug label specifications.
Asthmanefrin Racephinephrine Inhalation Solution Bronchodilator, For temporary relief of mild symptoms of intermittent asthma, Preservative Free, Sterile, For Oral Inhalation Only, 30 vials per box, Nephron Pharmaceuticals Corporation, NDC 0487-2784-01.
Mckesson Medical-Surgical Inc. Corporate Office
Class I - Dangerous
CGMP Deviations: products were stored outside the drug label specifications.
Lorazepam Injection, USP, 2mg/mL, 1 mL vial, 25 vial per carton, Rx Only, Novaplus, Manufactured by Hikma Berkeley Heights, NJ 07922. Carton NDC# 0641-6048-25, Vial NDC# 0641-6048-01
Hikma Pharmaceuticals USA
Class I - Dangerous
Failed Impurities/Degradation Specifications: Out-of-specification results observed for total related compounds during testing of retain samples.
Dakin's Solution, a) sodium hypochlorite 0.125%, quarter strength, NDC 0436-0672-16, b) sodium hypochlorite 0.25%, half strength, NDC 0436-0936-16, c) sodium hypochlorite 0.5% full strength, NDC 0436-0946-16, Antimicrobial, 473 mL (16 fl oz) bottle, Century Pharmaceuticals, Inc.
Mckesson Medical-Surgical Inc. Corporate Office
Class I - Dangerous
CGMP Deviations: products were stored outside the drug label specifications.
Alcohol Swabsticks, Antiseptic, 50 4" saturated individual packets per box, Manufactured for: Dynarex Corporation, NY 10962, Made in Mexico, NDC 67777-300-01 (current NDC) NDC# 67777-120-10 (discontinued)
Mckesson Medical-Surgical Inc. Corporate Office
Class I - Dangerous
CGMP Deviations: products were stored outside the drug label specifications.
Eye-stream, eye wash solution, sterile, 4 FL OZ (118 mL) bottle per box, Alcon, NDC 0065-0530-04.
Mckesson Medical-Surgical Inc. Corporate Office
Class I - Dangerous
CGMP Deviations: products were stored outside the drug label specifications.
Triple Antibiotic Ointment, Bacitracin zinc, Neomycin sulfate, Polymixin B sulfate, First Aid Antibiotic, Triple Antibiotic Ointment, 144 packets per box, Net wt. per packet 0.5 g, Honeywell Safety Products, NDC 0498-0750-36.
Mckesson Medical-Surgical Inc. Corporate Office
Class I - Dangerous
CGMP Deviations: products were stored outside the drug label specifications.
Lorazepam Injection, USP, 4mg/mL, 1 mL vial, 25 vial per carton, Rx Only, Novaplus, Manufactured by Hikma Berkeley Heights, NJ 07922. Carton NDC# NDC# 0641-6045-25, Vial NDC# 0641-6045-01
Hikma Pharmaceuticals USA
Class I - Dangerous
Failed Impurities/Degradation Specifications: Out-of-specification results observed for total related compounds during testing of retain samples.
Class I - Dangerous
Presence of foreign tablet: 2.5 mg tablet in a 20 mg bottle of Prednisone Tablets