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.
- 2022-11-09FDA-DrugPharmacy Plus, Inc. dba Vital Care CompounderClass IIPAPAVERINE / PHENTOLAMINE INJECTION 150MG / 5MG / VIAL SOLUTION, 10 mL vials, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402
Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products purported to be sterile.
- 2022-11-09FDA-DrugPharmacy Plus, Inc. dba Vital Care CompounderClass IIPAPAVERINE / PHENTOLAMINE / PROSTAGLANDIN INJ 90MG/3MG/29.4MCG/ BOTTLE SOLUTION, 5 ML vial, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402
Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products purported to be sterile.
- 2022-11-09FDA-DrugPharmacy Plus, Inc. dba Vital Care CompounderClass IIPAPAVERINE / PHENTOLAMINE / PROSTAGLANDIN INJ 75MG/2.5MG/50MCG/ BOTTLE SOLUTION, 5 ML vial, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402
Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products purported to be sterile.
- 2022-11-09FDA-DrugPharmacy Plus, Inc. dba Vital Care CompounderClass IIPAPAVERINE / PHENTOLAMINE / PROSTAGLANDIN INJ 150MG/10MG/100MCG/ BOTTLE SOLUTION, 5 ML vial, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402
Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products purported to be sterile.
- 2022-11-09FDA-DrugPharmacy Plus, Inc. dba Vital Care CompounderClass IIPAPAVERINE / PHENTOLAMINE / PROSTAGLANDIN 150MG / 2.5MG / 50MCG SOLUTION, 5 mL vials, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402
Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products purported to be sterile.
- 2022-11-09FDA-DrugPharmacy Plus, Inc. dba Vital Care CompounderClass IIPAP/PHEN/PROSTAG/ATROPINE INJ 150MG/7.5MG/75MCG/1MG bottle solution, 5 mL vials, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402
Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products purported to be sterile.
- 2022-11-09FDA-DrugPharmacy Plus, Inc. dba Vital Care CompounderClass IIMOXIFLOXACIN PRESERVATIVE FREE SYR, 0.15 mg/0.1 mL, Sterile Solution, 1 mL syringes, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402
Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products purported to be sterile.
- 2022-11-09FDA-DrugPharmacy Plus, Inc. dba Vital Care CompounderClass IIMITOMYCIN INJECTION 0.375 mg/mL SYR, 0.375 mg/mL solution, 1 mL syringe, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402
Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products purported to be sterile.
- 2022-11-09FDA-DrugPharmacy Plus, Inc. dba Vital Care CompounderClass IIMETHYLCOBALAMIN PF 1 ML Injection Solution 5,000 MCG/ML Solution, 1 mL vials, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402
Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products purported to be sterile.
- 2022-11-09FDA-DrugPharmacy Plus, Inc. dba Vital Care CompounderClass IIMEDROXYPROGESTERONE ACETATE 300 MG/ML Suspension, 10 mL vial, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402
Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products purported to be sterile.
- 2022-11-09FDA-DrugPharmacy Plus, Inc. dba Vital Care CompounderClass IILIDOCAINE EPINEPHRINE BUFFERED 2%/1:1000 Solution, 10 mL syringe, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402
Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products purported to be sterile.
- 2022-11-09FDA-DrugPharmacy Plus, Inc. dba Vital Care CompounderClass IILIDOCAINE/PHENYLEPHRINE PF SYR 1%/1.5% Solution, 3 mL syringes, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402
Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products purported to be sterile.
- 2022-11-09FDA-DrugPharmacy Plus, Inc. dba Vital Care CompounderClass IILAURETH-9 INJ 2% Solution, 30 ML vial, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402
Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products purported to be sterile.
- 2022-11-09FDA-DrugPharmacy Plus, Inc. dba Vital Care CompounderClass IIGLYCERIN OPHTHALMIC DROPS 98.5% Solution, 10 mL droptainer, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402
Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products purported to be sterile.
- 2022-11-09FDA-DrugPharmacy Plus, Inc. dba Vital Care CompounderClass IICYCLOSPORIN 0.07% OPTH 0.07% Solution in 10 mL bottles, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402
Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products purported to be sterile.
- 2022-11-09FDA-DrugPharmacy Plus, Inc. dba Vital Care CompounderClass IICEFUROXIME INTRAVITREAL SYR 1MG/0.1ML Solution in 1 mL syringe, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402
Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products purported to be sterile.
- 2022-11-09FDA-DrugPharmacy Plus, Inc. dba Vital Care CompounderClass IICEFTAZIDIME INTRAVITREAL 2.25MG/0.1ML Solution, 0.5 mL syringe, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402
Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products purported to be sterile.
- 2022-11-09FDA-DrugPharmacy Plus, Inc. dba Vital Care CompounderClass IIBRILLIANT BLUE G, 0.04% Solution, 2 mL vials, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402
Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products purported to be sterile.
- 2022-11-09FDA-DrugPharmacy Plus, Inc. dba Vital Care CompounderClass IIAUTOLOGUS TEARS SERUM SOLN FULL STRENGTH, 3 mL droptainers, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402
Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products purported to be sterile.
- 2022-11-09FDA-DrugPharmacy Plus, Inc. dba Vital Care CompounderClass IIACETYLCYSTEINE OPTH 5% Solution, 15 mL droptainers, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402
Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products purported to be sterile.
- 2022-11-09FDA-DrugPharmacy Plus, Inc. dba Vital Care CompounderClass IIACETYLCYSTEINE OPTH 10% Solution, 15 mL droptainers, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402
Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products purported to be sterile.
- 2022-11-09FDA-DrugGenentech IncClass IIISusvimo (ranibizumab injection), 100mg/mL, sold together as a) carton containing One Susvimo single-dose vial and One Susvimo initial fill needle, NDC 50242-078-55; and b) carton labeled as Susvimo Ocular Implant with Insertion Tool Assembly, containing One carrier with implant and One insertion Tool, UDI 81004259001, GTIN 00810042590014, Rx only, Genentech, Inc., A Member of the Roche Group, South San Francisco, CA 94080-4990.
Defective Delivery System: Commercial implants do not meet the filed specification for the intended use, a few patients have experienced an issue with the implants that renders it non-functioning.
- 2022-11-09FDA-DrugSUN PHARMACEUTICAL INDUSTRIES INCClass IIBuprenorphine and Naloxone Sublingual Tablets 8 mg/2 mg, 30-count bottles, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512 Manufactured by: Sun Pharmaceutical Industries Ltd. Survey No. 259/15, Dadra-396 191, (U.T. of D & NH), India; NDC 62756-970-83
Presence of Foreign Substance
- 2022-11-02FDA-DrugExela Pharma Sciences LLCClass I8.4% 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
- 2022-11-02FDA-DrugExela Pharma Sciences LLCClass I8.4% 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
- 2022-11-02FDA-DrugAurobindo Pharma USA Inc.Class IIQuinapril and Hydrochlorothiazide Tablets, USP 20mg/12.5mg, 90 Tablets bottles Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520, Made in India, NDC 65862-162-90
CGMP Deviations: Detection of N-Nitroso-quinapril impurity above the acceptable daily intake limit.
- 2022-11-02FDA-DrugAuroMedics Pharma LLCClass IIFondaparinux Sodium Injection, USP, 7.5 mg per 0.6 mL, Single Dose, Prefilled Syringe, Distributed by: AuroMedics Pharma LLC 279 Princeton-Hightstown Rd. E. Windsor, NJ 08520. Made in India. NDC 55150-232-10 (carton)NDC 55150-232-00 (syringe)
Subpotent Drug: Out of specification for assay
- 2022-11-02FDA-DrugGolden State Medical Supply Inc.Class IAtenolol Tablets, USP, 25 mg, 1000-count bottle, Rx only, Manufactured by: ALPHAPHARM PTY LTD, Marketed by: GSMS, Incorporated, Camarillo, CA 93012, USA, NDC 60429-027-10
Label Mix - up; a bottle labeled as Atenolol 25mg Tablets contained Clopidogrel 75mg Tablets
- 2022-11-02FDA-DrugVistaPharm, Inc.Class IIPyridostigmine Bromide Oral Solution, USP 60 mg/5 mL Delivers 5 mL, packaged in 5mL unit-dose cup, Rx only, Dist. by: VistaPharm, NDC 66689-406-01
cGMP Deviations: Out of specification for assay of one of the preservative ingredients.
- 2022-11-02FDA-DrugUltra Chem Labs CorpClass IIProton Armor, Anti-Microbial Alcohol-Free Foaming Hand Sanitizer, kills 99.99% of germs, Green Tea and Aloe, Family Safe, No Gels, Water Based, 24 Hour Germ Protection with Moisturizers for Sensitive Skin, a) 8 oz bottle, b) 32 oz bottle, and c) 1.7 fl oz or 50 mL bottle, Supplier details: Ultra Chem Labs, Ontario, CA, Active Ingredients - Benzalkonium Chloride 0.13% (antimicrobial), ULS 8357 0.33% (antimicrobial shield), NDC 79208-001-50.
Chemical Contamination and CGMP Deviations: trace amounts of methanol found in one of the components during the manufacturing process.
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