Drug and pharmaceutical recalls

17624 federal recalls on file. Federal recalls for prescription drugs, OTC medications, supplements, and pharmaceuticals. Sourced from the FDA and translated into plain English.

2023-01-18FDA-DrugNorthern VA Compounders PLLCClass II
QuadMix Super 001 (PGE1/Papaverine HCl/Phentolamine Mesylate/Atropine) 40mcg/30mg/2mg/0.4mg/mL INJECTABLE, packaged in 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166.
Lack of Assurance of Sterility
2023-01-18FDA-DrugNorthern VA Compounders PLLCClass II
QuadMix Standard 002 (PGE1/Papaverine HCl/Phentolamine Mesylate/Atropine) 10mcg/30mg/2mg/0.2MG/ML INJECTABLE, packaged in 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166.
Lack of Assurance of Sterility
2023-01-18FDA-DrugNorthern VA Compounders PLLCClass II
QuadMix Plus (PGE1/Papaverine HCl/Phentolamine Mesylate/Atropine) 20mcg/30mg/2mg/0.2mg/mL INJECTABLE, packaged in 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166.
Lack of Assurance of Sterility
2023-01-18FDA-DrugNorthern VA Compounders PLLCClass II
Mitomycin Injection Solution, 4mg/ml, packaged in a 10 mL Multiple-Dose vial, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166.
Lack of Assurance of Sterility
2023-01-18FDA-DrugDirect RxClass II
Moxifloxacin Ophthalmic Solution, 0.5%, 3 mL, Rx Only, Packaged and Distributed By: Direct Rx, LLC 94 Worldwide Drive, Dawsonville, GA 30534, NDC 72189-0334-05
cGMP deviation: discontinue of stability support for product.
2023-01-18FDA-DrugLupin Pharmaceuticals Inc.Class II
Rifampin Capsules USP, 300 mg, 30-count bottle; Rx Only, Manufactured for: Lupin Pharmaceuticals Baltimore, Maryland 21202, Manufactured by: Lupin Limited Aurangabad 431 210 India. NDC 68180-659-06
Failed Impurities/Degradation Specifications: Failure observed in related substance testing during long term stability study.
2023-01-18FDA-DrugNephron Sterile Compounding Center LLCClass II
Rocuronium Bromide Injection, 50 mg/5 mL (10 mg/mL), 5 x 5 mL Pre-Filled Syringe, 6 x 5 syringe carton, Rx Only, Nephron 503B outsourcing facility, 4500 12th Street Extension, West Columbia, SC 29172, NDC: 69374-924-05
Lack of Assurance of Sterility
2023-01-18FDA-DrugRemedyRepack Inc.Class II
Rifampin Capsules, 300 mg, 30 count blister card, Rx only, Mfg: Lupin Pharma, Baltimore, MD 21202, original NDC 68180-0659-07, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, Repackaged NDC 70518-2404-00.
Failed Impurities/Degradation specifications
2023-01-11FDA-DrugPine Pharmaceuticals, LLCClass II
Epi-Caine, Epinephrine 0.025% Lidocaine HCL 0.75% Solution for Intraocular Injection, 1 ml, Single Dose Vial, Compounded by Pine Pharmaceuticals, 355 Riverwalk Pkwy, Tonawanda, NY 14150. NDC 69194-0948-1
CGMP Deviations: Raw material recalled by repackager, due to discoloration.
2023-01-11FDA-DrugPfizer Inc.Class II
Heparin Sodium 2,000, USP Units, per 1,000 mL (2 USP Units/mL) in 0.9% Sodium Chloride Injection, 1,000 mL bags, a) Case (NDC 0409-7620-59), b) Single Unit (NDC 0409-7620-49), Rx only, Distributed By Hospira, Inc., Lake Forest, IL 60045 USA,
Lack of assurance of sterility: Bags have the potential to leak.
2023-01-11FDA-DrugJubilant Cadista Pharmaceuticals, Inc.Class III
Prochlorperazine Maleate Tablets, USP 5mg, 100 tablets, RX Only, Jubilant Cadista Pharmaceuticals, Inc., Salisbury, Maryland 21801, NDC 59746-113-06
Subpotent Drug: Out of specification for assay at the 18-month stability timepoint.
2023-01-11FDA-DrugEugia US LLCClass II
Acyclovir Sodium Injection 1,000 mg per 20 mL* (50 mg/mL); Single Dose 20mL Vial, Rx only, Distributed by: AuroMedics Pharma LLC, 279 Princeton-Hightstown Rd, E. Windsor, NJ 08520; Made in India. NDC 55150-155-20
Presence of Particulate Matter: Customer complaint of dark particles found inside the vial
2023-01-04FDA-DrugApotex Corp.Class III
Timolol Maleate Ophthalmic Solution, USP 0.5%, 2.5 mL, Rx Only, Mfg by: Apotex Inc. Toronto, Ontario Canada M9L 1T9 Mfg for: Apotex Corp. Weston, FL 33326, NDC 60505-1005-4
Failed Stability Specifications: Out of specification for weight loss at the 18-month stability timepoint and projected weight loss of 21.1% at shelf life.
2023-01-04FDA-DrugNCH Life Sciences LLCClass II
Alcohol Antiseptic 80% Topical Solution Hand Sanitizer, Non-Sterile Solution, packaged as a a) 2.5 gallon bottle (9,464 ml), NDC 55533-524-02, and b) 55 gallon bottle (208,198 ml), NDC 55533-524-03, Manufactured for: Multi-Mist Products A Division of NCH Corporation 1618 Northgate, Irving, Texas 75062
CGMP Deviations: Impurities of acetal and acetaldehyde were discovered in the product in excess of allowed limits.
2023-01-04FDA-DrugAVKARE LLCClass II
Glycopyrrolate Tablets, USP, 1 mg, 50 Tablets (5x10) Unit Dose carton, Rx Only, Manufactured for: AvKARE Pulaski, TN 38478, NDC 50268-363-15
Failed impurities/degradation specifications: Out of specification for unknown impurities.
2023-01-04FDA-DrugHikma Pharmaceuticals USA Inc.Class II
Ganciclovir for Injection, USP, 500mg per vial, packaged in a 10-count carton, Rx Only, Mfd. by: THYMOORGAN PHARMAZIE GmbH, Germany, Distributed by Hikma Berkeley Heights, NJ 07922, NDC 0143-9299-01
Labeling: Label mix-up - one vial was mislabeled as Cladribine Injection 10mg/mL inside a 10-count carton of Ganciclovir 500 mg.
2022-12-28FDA-DrugLupin Pharmaceuticals Inc.Class II
Quinapril Tablets USP, 20 mg (90 pack), Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, by: Lupin Limited, Goa 403 722 India, NDC# 68180-558-09
CGMP Deviations: Detection of N-Nitroso-quinapril impurity above the acceptable daily intake limit.
2022-12-28FDA-DrugLupin Pharmaceuticals Inc.Class II
Quinapril Tablets USP, 40 mg (90 pack), Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, by: Lupin Limited, Goa 403 722 India, NDC# 68180-554-09
CGMP Deviations: Detection of N-Nitroso-quinapril impurity above the acceptable daily intake limit.
2022-12-28FDA-DrugAurolife Pharma, LLCClass II
Glycopyrrolate Tablets, USP, 1 mg, 100 tablets, Rx Only, Distributed by: Aurobindo Pharma USA, Inc., East Windsor, NJ 08520, NDC 13107-014-01
Failed Impurities/Degradation Specifications
2022-12-28FDA-DrugSUN PHARMACEUTICAL INDUSTRIES INCClass II
Oxcarbazepine Tablets 600mg, packaged in a) 100- count bottles (NDC 62756-185-88), b) 500-count bottles (NDC 62756-185-13), c)1000-count bottles (NDC 62756-185-18), Rx Only, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Limited Halol-Baroda Highway, Halol-389 350, Gujarat, India.
Presence of foreign substance
2022-12-21FDA-DrugCamber Pharmaceuticals, IncClass III
Lacosamide Oral Solution, USP, CV, 10mg/mL, packaged in 200 mL bottle, Rx Only, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854, Manufactured By: HETERO LABS LIMITED, Jeedimetla, Hyderabad - 500 055, India, NDC 31722-627-26
Failed Excipient Specifications: out of specification result observed for p-Hydroxybenzoic Acid content
2022-12-21FDA-DrugBayCare Integrated Service Center, LLC /dba BayCare Central PharmacyClass I
Iohexol (300 mg Iodine/mL), 2.4 g Iodine/8 ml, Total Volume 8 ml in 10 ml syringe, 5-count syringes packaged in a bag labeled as Omnipaque (iohexol) 300 mg I/mL, 2.4g Iodine/8 mL in a 10 mL syringe, Compounded with GE Healthcare product, Each mL contains (647 mg) of iohexol as 300 mg of organically bound iodine, 1.21 mg tromethamine, and 0.1 mg edetate calcium disodium, For Injection or oral use; Rx Only, BayCare Central Pharmacy, 7802 Telecom Parkway, Temple Terrace, FL 33637.
Labeling: Label Error on Declared Strength: syringes mislabeled as 300 mg iodine/mL contained product 350 mg iodine/mL
2022-12-21FDA-DrugAtlantic Management Resources Ltd.Class II
Menastil, A Homeopathic Formula, Calendula Oil packaged in 1/8 Fl. oz. (3.5 g) bottles, Mfg. for/Dist. By Claire Ellen Topicals, P.O. Box 901 Westborough, MA 01581, USA, NDC# 66233-711-01.
cGMP Deviations
2022-12-21FDA-DrugAtlantic Management Resources Ltd.Class II
ProSirona, A Homeopathic Formula, Calendula Oil packaged in 1/8 Fl. oz. (3.5 g) bottles, Dist. by: Endometriosis Assoc. Inc. (International), Mfg. by Claire Ellen Topicals, P.O. Box 901 Westborough, MA 01581, USA, NDC# 66233-712-01.
cGMP Deviations
2022-12-21FDA-DrugAtlantic Management Resources Ltd.Class II
Neuroquell, A Homeopathic Drug, Calendula Oil, packaged in1/8 Fl. oz. (3.5 g) bottles, Mfg. for/Dist. By Claire Ellen Topicals, P.O. Box 901 Westborough, MA 01581, USA, NDC# 66233712-01.
cGMP Deviations
2022-12-21FDA-DrugAtlantic Management Resources Ltd.Class II
Neuroquell Plus, Advanced Formula, A Homeopathic Drug, Calendula Oil packaged in 0.22 Fl. oz. (6.6 mL) bottles, Mfg. for/Dist. By Claire Ellen Topicals, P.O. Box 901 Westborough, MA 01581, USA, NDC# 66233712-01.
cGMP Deviations
2022-12-21FDA-DrugExela Pharma Sciences LLCClass I
8.4% Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL) 50 mL Single Dose Vials, packaged in cartons of 20 vials, Rx Only, Mfd for: Civica, Inc. Lehi, Utah 84043, Mfd by: Exela Pharma Sciences, LLC, Lenoir, NC 28645, Carton NDC 72572-740-20, vial NDC 72572-740-1.
Defective Container: Complaints received of vial breakage and glass flying when pressurized while preparing the product for administration.
2022-12-21FDA-DrugExela Pharma Sciences LLCClass I
8.4% Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL) 50 mL Single Dose Vials, packaged in cartons of 20 vials, Rx only, Manufactured and Distributed by: Exela Pharma Sciences, LLC Lenoir, NC 28645. Carton NDC 51754-5001-5, vial NDC 51754-5001-1.
Defective Container: Complaints received of vial breakage and glass flying when pressurized while preparing the product for administration.
2022-12-21FDA-DrugOurPharma LLCClass II
FentaNYL Citrate 2.5 mg/50 mL (50mcg/ml) Injection Solution, Preservative Free, Single Use 50 ml Cassette, Rx Only, Repackaged by OurPharma, LLC. 2512 S. City Lake Rd. Fayetteville, AR 72701, 1-833-290-2654, NDC 73013-001-01
Underfilled units.
2022-12-14FDA-DrugRemedyRepack Inc.Class II
Desmopressin Acetate Tablet, 0.2 mg, 100-count box, Rx only, Source NDC: 23155-0490-01; MFG: Avet Pharmaceuticals Inc., East Brunswick, NJ 08816; Repackaged by: RemedyRepack Inc., Indiana, PA 15701, NDC #: 70518-3493-00.
Subpotent Drug: repackaged product was recalled by the manufacturer for subpotency.

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