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.
- 2021-05-05FDA-DrugCareFusion 213, LLCClass IIBD ChloraPrep Clear, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Sterile Solution, 0.10 fl. oz. (3 ml) each, 25 Applicators in carton, applicator is sterile if package is intact. CareFusion 213, LLC, El Paso, TX 79912, subsidiary of Becton, Dickinson and Co, NDC 54365-400-32 REF 930400
Lack of Assurance of Sterility: Product is being recalled because at labeled storage conditions of 30*C/75% Relative Humidity, there is the potential for growth of Aspergillus penicillioides, a type of fungus, resulting in a breach of the package integrity.
- 2021-05-05FDA-DrugCareFusion 213, LLCClass IChloraPrep With Tint 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Non-Sterile Solution - Hi-Lite Orange, 0.10 fl. oz. (3 ml) each, 25 applicators in carton, applicator is sterile if package is intact. CareFusion El Paso, TX 79912, NDC 054365-400-11 Cat. No. 260415
Microbial Contamination of Non-Sterile Product:.Product is being recalled because at labeled storage conditions of 30*C/75% Relative Humidity, growth of Aspergillus penicillioides, a type of fungus, resulted in a breach of the package integrity.
- 2021-05-05FDA-DrugCareFusion 213, LLCClass IChloraPrep One-Step 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Non-Sterile Solution -Clear, 0.10 fl. oz. (3ml) each, 25 applicators per carton, applicator is sterile if package is intact. CareFusion El Paso, TX 79912, NDC 054365-400-01 Cat. No. 260400
Microbial Contamination of Non-Sterile Product.Product is being recalled because at labeled storage conditions of 30*C/75% Relative Humidity, growth of Aspergillus penicillioides, a type of fungus, resulted in a breach of the package integrity.
- 2021-05-05FDA-DrugCareFusion 213, LLCClass IBD ChloraPrep Hi-Lite Orange 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA), Sterile Solution, 0.10 fl. oz. (3 ml) each, 25 Applicators in carton, applicator is sterile if package is intact. CareFusion El Paso, TX 79912, subsidiary of Becton, Dickinson and Co., NDC 54365-400-33 REF 930415
Non-sterility.Product is being recalled because at labeled storage conditions of 30*C/75% Relative Humidity, growth of Aspergillus penicillioides, a type of fungus, resulted in a breach of the package integrity.
- 2021-05-05FDA-DrugCareFusion 213, LLCClass IBD ChloraPrep Clear, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Sterile Solution, 0.10 fl. oz. (3 ml) each, 25 Applicators in carton, applicator is sterile if package is intact. CareFusion 213, LLC, El Paso, TX 79912, subsidiary of Becton, Dickinson and Co, NDC 54365-400-32 REF 930400
Non-sterility.Product is being recalled because at labeled storage conditions of 30*C/75% Relative Humidity, growth of Aspergillus penicillioides, a type of fungus, resulted in a breach of the package integrity.
- 2021-05-05FDA-DrugPreferred Pharmaceuticals, Inc.Class IICephalexin for Oral Suspension, Generic for Keflex, USP, Powder for Oral Suspension, 250 mg/5mL, Pkg Size 100, Rx only, Repackaged by Preferred Pharmaceuticals, Inc., Mfg: Ascend Laboratories, LLC, NDC #: 68788-7529-1,
Failed Impurities/degradation specifications: Repackager recall due to Out of Specification detected by manufacturer for Individual Unidentified Impurity found during related substance test analysis of Cephalexin
- 2021-05-05FDA-DrugPD-Rx Pharmaceuticals, Inc.Class IILosartan Potassium USP, 50 mg, RX Only, Pkg By PD-Rx Pharmaceuticals Incorporated Oklahoma City, OK 73127 a) 60 Tablets NDC: 43063-854-60; b) 90 Tablets NDC: 43063-0854-90
CGMP deviation: Product found to contain trace amounts of NMBA
- 2021-05-05FDA-DrugTeligent Pharma, Inc.Class IIIBetamethasone Dipropionate Ointment USP, 0.05% (Augmented), packaged in 15 grams tubes, Manufactured by: Teligent Pharma, Inc. Buena, New Jersey 08310, Distributed by: McKesson Corporation dba Sky Packaging 4971 Southbridge Blvd., Suite 101 Memphis, TN 38141, NDC 63739-996-15
Failed Impurities/ Degradation Specifications - OOS for know impurity Betamethasone 17- propionate.
- 2021-05-05FDA-DrugTeligent Pharma, Inc.Class IIIBetamethasone Dipropionate Ointment USP, 0.05% (Augmented), packaged in 50 grams tubes, Manufactured by: Teligent Pharma, Inc. Buena, New Jersey 08310, NDC 52565-019-51
Failed Impurities/ Degradation Specifications - OOS for know impurity Betamethasone 17- propionate.
- 2021-05-05FDA-DrugTeligent Pharma, Inc.Class IIIBetamethasone Dipropionate Ointment USP, 0.05% (Augmented), packaged in 15 grams tubes, Manufactured by: Teligent Pharma, Inc. Buena, New Jersey 08310, NDC 52565-019-15
Failed Impurities/ Degradation Specifications - OOS for know impurity Betamethasone 17- propionate.
- 2021-04-28FDA-DrugTeligent Pharma, Inc.Class IIFlurandrenolide Ointment USP, 0.05%, Net Wt. 60 grams, Rx Only, Teligent Pharma, Inc. Buena, New Jersey 08310 NDC 52565-017-60
Failed Impurities/Degradation Specifications:
- 2021-04-28FDA-DrugNoven Pharmaceuticals IncClass IIEstradiol Transdermal System Delivers 0.0375 mg/day, 8 Systems/box, Rx only, Mfd. by: Noven Pharmaceuticals, Inc. Miami, Florida 33186 Dist. by: Noven Therapeutics, LLC Miami, Florida 33186, NDC 68968-3437-8
Defective Delivery System: Out of specification for release rate testing and shear, an attribute related to the adhesive properties of the transdermal patches. As a result, patients could experience patches that do not stick well to the skin.
- 2021-04-28FDA-DrugNoven Pharmaceuticals IncClass IIMinivelle (estradiol transdermal system) Delivers 0.075 mg/day, 8 patches/box, Rx only, Mfd. by: Noven Pharmaceuticals, Inc. Miami, Florida 33186 Dist. by: Noven Therapeutics, LLC Miami, Florida 33186, NDC 68968-6675-8
Defective Delivery System: Out of specification for release rate testing and shear, an attribute related to the adhesive properties of the transdermal patches. As a result, patients could experience patches that do not stick well to the skin.
- 2021-04-28FDA-DrugEdge Pharma, LLCClass IIBetadine (Povidone-Iodine) 5%, 0.5mL per syringe Single Use Syringe Rx only, For Topical Ophthalmic Use (DO NOT INJECT) STERILE OPHTHALMIC SOLUTION, PRESERVATIVE FREE, Edge Pharma, LLC 856 Hercules Dr. Colchester, VT 05446 Customer Service (USA) 1-802-992-1178
Defective container; syringe content migrating past the seal of the plunger may cause a lack of assurance of sterility
- 2021-04-21FDA-DrugNovo Nordisk IncClass IXultophy 100/3.6 (insulin degludec and liraglutide injection), 100 units/mL and 3.6 mg/mL, 3 mL Prefilled Pen, SAMPLE, Rx only, Manufactured by: Novo Nordisk A/S, Bagsvaerd, Denmark, Distributed by: Novo Nordisk Inc, Plainsboro, NJ 08536, NDC 0169-2911-90 (Pen) NDC 0169-2911-97 (Kit)
Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accordance with storage requirements that could cause a lack of efficacy and damage to the cartridge and pen-injectors.
- 2021-04-21FDA-DrugNovo Nordisk IncClass IIViCTOZA (liraglutide) injection, 18 mg/3 mL (6 mg/mL), contains: 1 Victoza Pen, Sample Not for Resale, Rx only, Manufactured by: Novo Nordisk A/S, Bagesvaerd, Denmark NDC 0169-4060-90 (Pen), 0169-4060-99 (Kit)
Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accordance with storage requirements that could cause a lack of efficacy and damage to the cartridge and pen-injectors.
- 2021-04-21FDA-DrugNovo Nordisk IncClass ITRESIBA FlexTouch (insulin degludec injection) 200 units/mL (U-200), 3 mL Prefilled Pen, Sample, Rx only, Manufactured by: Novo Nordisk A/S, Bagsvaerd, Denmark, Distributed by: Novo Nordisk Inc, Plainsboro, NJ 08536, NDC 0169-2550-90 (Pen), 0169-2550-97 (Kit)
Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accordance with storage requirements that could cause a lack of efficacy and damage to the cartridge and pen-injectors.
- 2021-04-21FDA-DrugNovo Nordisk IncClass ITRESIBA (insulin degludec injection) 100 units/mL (U-100), One 10 mL multi-dose vial, Sample. Not for Resale, Rx only, Manufactured by: Novo Nordisk A/S, Bagsvaerd, Denmark, NDC 0169-2662-90
Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accordance with storage requirements that could cause a lack of efficacy and damage to the cartridge and pen-injectors.
- 2021-04-21FDA-DrugNovo Nordisk IncClass ITRESIBA FlexTouch (insulin degludec injection) 100 units/mL (U-100), 3 mL Prefilled Pen, Sample, Rx only, Manufactured by: Novo Nordisk A/S, Bagsvaerd, Denmark, Distributed by: Movo Mordisk Inc., Plainsboro, NJ 08536, NDC 0169-2660-90 (Pen), NDC 0169-2660-97 (Kit)
Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accordance with storage requirements that could cause a lack of efficacy and damage to the cartridge and pen-injectors.
- 2021-04-21FDA-DrugNovo Nordisk IncClass IISaxenda (liraglutide) Injection, 18 mg/3 mL (6 mg/mL), 1 x 3 mL Prefilled Pen, Sample. Not for Resale., Rx only, Novo Nordisk Inc., Plainsboro, NJ 08536, Manufactured by: Novo Nordisk A/S, Bagsvaerd, Denmark, NDC 0169-2800-90 (Pen), NDC 0169-2800-97 (Kit)
Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accordance with storage requirements that could cause a lack of efficacy and damage to the cartridge and pen-injectors.
- 2021-04-21FDA-DrugNovo Nordisk IncClass IIOZEMPIC (semaglutide) injection, 2 mg/1.5 mL (1.34 mg/mL) Prefilled pen, 1 pen, Sample. Not for Resale, Rx only, Novo Nordisk Inc, Plainsboro, NJ 08536, Manufactured by: Novo Nordisk A/S, Bagsvaerd, Denmark, NDC 0169-4132-90 (Pen), NDC 0169-4132-97 (Kit)
Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accordance with storage requirements that could cause a lack of efficacy and damage to the cartridge and pen-injectors.
- 2021-04-21FDA-DrugNovo Nordisk IncClass INovoLog (Insulin aspart) Injection, 100 units/mL (U-100), One 10 mL multi-dose vial, Sample. Not for Resale, Rx Only, Manufactured by: Novo Nordisk A/S, Bagsvaerd, Denmark NDC 0169-7501-90
Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accordance with storage requirements that could cause a lack of efficacy and damage to the cartridge and pen-injectors.
- 2021-04-21FDA-DrugNovo Nordisk IncClass INovoLog FlexPen (insulin aspart) Injection, 100 units/mL, 3 mL Prefilled Insulin Syringe pen, Sample. Not for Resale, Rx Only, Novo Nordisk Inc., Plainsboro, NJ 08536, NDC 0169-6339-90 (Pen), NDC 0169-6339-98 (Kit)
Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accordance with storage requirements that could cause a lack of efficacy and damage to the cartridge and pen-injectors.
- 2021-04-21FDA-DrugNovo Nordisk IncClass ILevemir FlexTouch (insulin detemir) injection, 100 units/mL (U-100), 3 mL Prefilled Pen, Sample, Rx Only, Manufactured by: Novo Nordisk A/S, Bagsvaerd, Denmark, Distributed by: Novo Nordisk Inc., Plainsboro, NJ 08536, NDC 0169-6438-90 (Pen), NDC 0169-6438-98 (Kit)
Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accordance with storage requirements that could cause a lack of efficacy and damage to the cartridge and pen-injectors.
- 2021-04-21FDA-DrugNovo Nordisk IncClass IFiasp (insulin aspart injection), 100 units/mL (U-100), One 10 mL multi-dose vial, Sample. Not for Resale, Rx Only, Manufactured by: Novo Nordisk A/S, Bagsvaerd, Denmark, NDC 0169-3201-90
Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accordance with storage requirements that could cause a lack of efficacy and damage to the cartridge and pen-injectors.
- 2021-04-21FDA-DrugNovo Nordisk IncClass IFiasp PenFill (insulin aspart injection) 100 units/mL (U-100), 3 mL cartridge, 5 cartridges per package, Sample Not for Resale, Rx Only, Manufactured by: Novo Nordisk A/S, Bagsvaerd, Denmark, NDC 0169-3205-91
Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accordance with storage requirements that could cause a lack of efficacy and damage to the cartridge and pen-injectors.
- 2021-04-21FDA-DrugNovo Nordisk IncClass IFiasp FlexTouch (insulin aspart injection) 100 units/mL (U-100), 3 mL Prefilled Pen, Sample. Not for Resale, Rx only, Manufactured by: Novo Nordisk, Inc., Bagsvaerd, Denmark, Distributed by: Novo Nordisk Inc, Plainsboro, NJ 08536, NDC 0169-3204-90 (Pen), NDC 0169-3204-97 (Kit)
Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accordance with storage requirements that could cause a lack of efficacy and damage to the cartridge and pen-injectors.
- 2021-04-21FDA-DrugSpartan Chemical Co IncClass IILite'n Foamy Healthcare Personnel Handwash (Chloroxylenol, 1.0%), Net Contents: 18 oz/ 532 ml per foam pump container, For Institutional and Industrial Use Only, Spartan Chemical Company, Inc., 1110 Spartan Drive, Maumee, OH 43537 USA. UPC 7 53727 26283 0 NDC: 64009-335-82
CGMP Deviations
- 2021-04-21FDA-DrugSpartan Chemical Co IncClass IILite'n Foamy Eucalyptus Mint Sanitizing Handwash (Benzalkonium Chloride, 0.13%), Net Contents: 18 oz/ 532 ml per foam pump container, For Institutional and Industrial Use Only, Spartan Chemical Company, Inc., 1110 Spartan Drive, Maumee, OH 43537 USA. UPC 7 53525 26287 8 NDC: 64009-332-72
CGMP Deviations
- 2021-04-21FDA-DrugSpartan Chemical Co IncClass IILite'n Foamy E2 Sanitizing Handwash (Benzalkonium Chloride, 0.13%), Net Contents: 1 US Gallon/ 3.79 Liters per gallon container, For Institutional and Industrial Use Only, Spartan Chemical Company, Inc., 1110 Spartan Drive, Maumee, OH 43537 USA. UPC 7 53727 26116 1 NDC: 64009-333-95
CGMP Deviations
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