Drug Recall
Terminated
Historical recordClass II
20% Acetyl-L-Cysteine Ophthalmic Solutions, dispensed in 3ml dropper bottle.
by Compounded Solutions in Pharmacy
- Reason
- Lack of Processing Controls:
- Recall initiated
- September 3, 2019
- Reported by FDA
- September 18, 2019
- Distribution
- Product was dispensed to patients
View recall →
Drug Recall
Terminated
Historical recordClass II
Bacteriostatic Water for Injection, USP, 30 mL vials, Rx only, Mfd. for: Hospira, Inc., Lake Forest, IL 60045 USA. NDC Vial: 0409-3977-01; NDC Carton: 0409-3977-03
by Pfizer Inc.
- Reason
- Lack of Assurance of Sterility
- Recall initiated
- September 6, 2019
- Reported by FDA
- September 18, 2019
- Distribution
- Nationwide US and Puerto Rico
View recall →
Drug Recall
Terminated
Historical recordClass III
Pramipexole Dihydrochloride Tablets 0.125 mg,90-count bottle, Rx Only, Manufactured for: Macleods Pharma USA, Inc. Plainsboro, NJ 08536, Manufactured by: Macleods Phamaceuticals Ltd. Baddi Himachal Pradesh, India. NDC 33342-031-10
by Macleods Pharma Usa Inc
- Reason
- Subpotent Drug: Out of specification result during stability study in Pramipexole Dihydrochloride Tablets 0.125 mg
- Recall initiated
- August 21, 2019
- Reported by FDA
- September 18, 2019
- Distribution
- Distributed Nationwide in the USA
View recall →
Drug Recall
Terminated
Historical recordClass II
Bevacizumab, 1.25 mg/0.05 mL, 31G MJ Syringe Intravitreal Injection, Single use only, Rx only, Repackaged by AmEx Pharmacy 1515 Elizabeth St. Suite J Melbourne, FL 32901
by Pacifico National, Inc. dba AmEx Pharmacy
- Reason
- Lack of assurance of sterility.
- Recall initiated
- August 30, 2019
- Reported by FDA
- September 18, 2019
- Distribution
- Continental U.S. and Puerto Rico
View recall →
Drug Recall
Terminated
Historical recordClass II
Bevacizumab, 2.5 mg/0.1 mL, Norm-Ject Syringe Intravitreal Injection, Single use only, Rx only, Repackaged by AmEx Pharmacy 1515 Elizabeth St. Suite J Melbourne, FL 32901
by Pacifico National, Inc. dba AmEx Pharmacy
- Reason
- Lack of assurance of sterility.
- Recall initiated
- August 30, 2019
- Reported by FDA
- September 18, 2019
- Distribution
- Continental U.S. and Puerto Rico
View recall →
Drug Recall
Terminated
Historical recordClass III
Gatifloxacin Ophthalmic Solution 0.5%, 2.5 mL per bottle, Rx Only, Mfd. for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505. Made in India. NDC: 0378-5431-35
by Mylan Pharmaceuticals Inc.
- Reason
- Failed Impurities/Degradation Specifications:OOS for unknown impurity.
- Recall initiated
- September 6, 2019
- Reported by FDA
- September 18, 2019
- Distribution
- Nationwide in the USA
View recall →
Drug Recall
Terminated
Historical recordClass III
Lamivudine Tablets, USP, 150 mg, 30 (3x10) count Unit Dose Blisters Carton, NDC 60687-362-21 (Individual Dose NDC: 60687-362-11), Distributed by American Health Packaging, Columbus, OH
by American Health Packaging
- Reason
- Labeling: Incorrect or Missing Package Insert; an error in the Dosage Forms and Strengths section of the insert that incorrectly lists the tablet description coding for the tablets.
- Recall initiated
- August 27, 2019
- Reported by FDA
- September 18, 2019
- Distribution
- Nationwide
View recall →
Drug Recall
Terminated
Historical recordClass II
Vivitrol (naltrexone for extended-release injectable suspension) 380 mg/vial. Each Carton Contains: 1) One vial of 380 mg of Vivitrol, 2) One vial containing 4 mL of diluent, 3) One 5-mL prepackaged syringe, 4) One 20-gauge 1-inch needle, 5) Two 20-gauge 1.5-inch safety needles, 6) Two 20-gauge 2-inch safety needles. Rx Only. Manufactured and marketed by: Alkermes, Inc. Kit NDC: 65757-300-01
by Alkermes Inc
- Reason
- Labeling: Not Elsewhere Classified. Drug product kit recalled due to 1 inch needles being placed in the 1 1/2 inch needle cardboard sleeve labelled as administration needles. The product vial is not impacted.
- Recall initiated
- August 8, 2019
- Reported by FDA
- September 4, 2019
- Distribution
- Distributed Nationwide in the USA
View recall →
Drug Recall
Terminated
Historical recordClass II
RELPAX (eletriptan HBr) tablets, 40 mg, packaged in a) 6-count (1 card x 6 tablets) per carton, NDC 0049-2340-45; b) 12-count (2 cards x 6 tablets) per carton, NDC 0049-2340-05, Rx only, Made in Ireland, Distributed by Pfizer Roerig, Division of Pfizer Inc., NY, NY 10017.
by Pfizer Inc.
- Reason
- Microbial Contamination of Non-Sterile Products: contamination with Burkholderia and Pseudomonas.
- Recall initiated
- August 14, 2019
- Reported by FDA
- September 4, 2019
- Distribution
- Nationwide in the USA and Puerto Rico.
View recall →
Drug Recall
Terminated
Historical recordClass III
Simvastatin Tablets, USP 40 mg. Rx Only 1000 Count Bottles Manufactured by: Aurolife Pharma LLC Dayton NJ 08810 Manufactured for: Aurobindo Pharma USA, Inc. Dayton, NJ 08810 NDC 65862-053-99
by Aurobindo Pharma USA Inc.
- Reason
- Labeling; Incorrect or Missing Lot and/or Exp Date; some bottles labeled with lot number 05318054B instead of 05318034B
- Recall initiated
- July 29, 2019
- Reported by FDA
- September 4, 2019
- Distribution
- Product was distributed nationwide by three major distributors who may have further distributed the product.
View recall →
Drug Recall
Terminated
Historical recordClass III
Eptifibatide Injection, a) 20 mg/10 mL (2 mg/mL),10 mL Single Use Vial, NDC 17478-902-10, b) 200 mg/100 mL (2 mg/mL), 100 mL Single-use Vial, NDC 17478-902-90, For Intravenous Use Only, Rx Only, Manufactured by: Akorn Inc., Lake Forest, IL 60045.
by Akorn, Inc.
- Reason
- Failed Impurities/Degradation Specifications: Out of Specification (OOS) for known impurity, D-aspartic acid.
- Recall initiated
- August 6, 2019
- Reported by FDA
- September 4, 2019
- Distribution
- Nationwide in the U.S.
View recall →
Drug Recall
Terminated
Historical recordClass III
Eptifibatide Injection, 75 mg/100 mL (0.75 mg/mL), 100 mL Single-use Vial, For Intravenous Use Only, Rx Only, Manufactured by: Akorn Inc., Lake Forest, IL 60045, NDC 17478-903-90.
by Akorn, Inc.
- Reason
- Short Fill: fill volume was out of specification at 94 mL (specification: no less than 100 mL) and Failed Impurities/Degradation Specifications: Out of Specification (OOS) for known impurity, D-aspartic acid.
- Recall initiated
- August 6, 2019
- Reported by FDA
- September 4, 2019
- Distribution
- Nationwide in the U.S.
View recall →
Drug Recall
Terminated
Historical recordClass III
Eptifibatide Injection, 75 mg/100 mL (0.75 mg/mL), 100 mL Single-use Vial, For Intravenous Use Only, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045, NDC 17478-903-90.
by Akorn, Inc.
- Reason
- Failed Impurities/Degradation Specifications: Out of Specification (OOS) for known impurity, D-aspartic acid.
- Recall initiated
- August 6, 2019
- Reported by FDA
- September 4, 2019
- Distribution
- Nationwide in the U.S.
View recall →
Drug Recall
Terminated
Historical recordClass II
Ketamine 50 mg/5 mL in 0.9% Sodium Chloride Injection for IV or IM Use (concentration = 10 mg/mL), 6 mL Syringe, Rx Only, SCA Pharmaceuticals, Windsor, CT 06095, NDC 70004-0430-09.
by SCA Pharmaceuticals, LLC
- Reason
- Lack of Assurance of Sterility.
- Recall initiated
- August 16, 2019
- Reported by FDA
- August 28, 2019
- Distribution
- Nationwide in the U.S.
View recall →
Drug Recall
Terminated
Historical recordClass II
Bexarotene Capsules, 75 mg, 100 capsules per bottle, Rx Only, Manufactured for: Upsher-Smith Laboratories, LLC, Maple Grove, MN 55369. NDC: 0832-0285-00
by Upsher Smith Laboratories, Inc.
- Reason
- Failed Dissolution Specifications
- Recall initiated
- July 29, 2019
- Reported by FDA
- August 28, 2019
- Distribution
- KY, OH, NJ, LA
View recall →
Drug Recall
Terminated
Historical recordClass II
Clear Eyes Redness Relief Hand Pocket Pal Tray Display; each display (UPC 6 78112 25418 7) contains 48 each of Clear eyes REDNESS RELIEF (Glycerin 0.25%, Naphazoline hydrochloride 0.012%) eye drops, 0.2 FL OZ (6 mL) bottle, Handy Pocket Pal (UPC 6 78112 25418 7); Distributed by Medtech Products Inc., Tarrytown, NY 10591 A Prestige Brands Company.
by Medtech Products, Inc.
- Reason
- CGMP Deviations: concerns regarding the sufficiency of Quality Assurance controls over critical systems in the manufacturing facility that could impact the product quality of the finished products.
- Recall initiated
- July 26, 2019
- Reported by FDA
- August 28, 2019
- Distribution
- Nationwide in the USA and Puerto Rico, St. Michael, Barbados, Guyana, St. Johns, Antigua and Barbuda, Kingston 5, and Jamaica.
View recall →
Drug Recall
Terminated
Historical recordClass II
Clear eyes REDNESS RELIEF (Glycerin 0.25%, Naphazoline hydrochloride 0.012%) eye drops, Handy Pocket Pal, 0.2 FL OZ (6 mL) bottle, Distributed by Select Corporation, Carrolton, TX 75007; Medtech Products Inc., Tarrytown, NY 10591, A Prestige Brands Company, UPC 6 55708 01039 6.
by Medtech Products, Inc.
- Reason
- CGMP Deviations: concerns regarding the sufficiency of Quality Assurance controls over critical systems in the manufacturing facility that could impact the product quality of the finished products.
- Recall initiated
- July 26, 2019
- Reported by FDA
- August 28, 2019
- Distribution
- Nationwide in the USA and Puerto Rico, St. Michael, Barbados, Guyana, St. Johns, Antigua and Barbuda, Kingston 5, and Jamaica.
View recall →
Drug Recall
Terminated
Historical recordClass II
Clear Eyes Redness Relief Handy Pocket Pal Club Pak Display; each display (case UPC 30300742541283) contains 48 each of Clear eyes REDNESS RELIEF (Glycerin 0.25%, Naphazoline hydrochloride 0.012%) eye drops, 0.2 FL OZ (6 mL) bottle, Handy Pocket Pal (UPC 6 78112 25418 7); Distributed by Medtech Products Inc., Tarrytown, NY 10591; A Prestige Brands Company.
by Medtech Products, Inc.
- Reason
- CGMP Deviations: concerns regarding the sufficiency of Quality Assurance controls over critical systems in the manufacturing facility that could impact the product quality of the finished products.
- Recall initiated
- July 26, 2019
- Reported by FDA
- August 28, 2019
- Distribution
- Nationwide in the USA and Puerto Rico, St. Michael, Barbados, Guyana, St. Johns, Antigua and Barbuda, Kingston 5, and Jamaica.
View recall →
Drug Recall
Terminated
Historical recordClass II
Clear Eyes Maximum Itchy Eye Relief Sidekick Floor Stand Display; each display (case UPC 10678112736383) contains 12 each of Clear eyes MAXIMUM ITCHY EYE RELIEF (Glycerin 0.25%, Naphazoline hydrochloride 0.012%, Zinc Sulfate 0.25%) eye drops, 0.5 FL OZ (15 mL) bottle, (UPC 6 78112 65920 3), Distributed by Medtech Products Inc., Tarrytown, NY 10591, A Prestige Brands Company.
by Medtech Products, Inc.
- Reason
- CGMP Deviations: concerns regarding the sufficiency of Quality Assurance controls over critical systems in the manufacturing facility that could impact the product quality of the finished products.
- Recall initiated
- July 26, 2019
- Reported by FDA
- August 28, 2019
- Distribution
- Nationwide in the USA and Puerto Rico, St. Michael, Barbados, Guyana, St. Johns, Antigua and Barbuda, Kingston 5, and Jamaica.
View recall →
Drug Recall
Terminated
Historical recordClass II
Clear Eyes Maximum Redness Relief Club Pack Display; each display contains 18 3-Pack bottles (UPC 6 78112 10859 6) of Clear eyes MAXIMUM REDNESS RELIEF (Glycerin 0.5%, Naphazoline hydrochloride 0.03%) eye drops, 0.5 FL OZ (15 mL) bottle, (UPC 6 78112 66577 8); Distributed by Medtech Products Inc., Tarrytown, NY 10591, A Prestige Brands Company.
by Medtech Products, Inc.
- Reason
- CGMP Deviations: concerns regarding the sufficiency of Quality Assurance controls over critical systems in the manufacturing facility that could impact the product quality of the finished products.
- Recall initiated
- July 26, 2019
- Reported by FDA
- August 28, 2019
- Distribution
- Nationwide in the USA and Puerto Rico, St. Michael, Barbados, Guyana, St. Johns, Antigua and Barbuda, Kingston 5, and Jamaica.
View recall →
This information is republished from FDA's Recall Enterprise System through openFDA. Public Health Trace
does not verify or supplement it, is not affiliated with the FDA, and does not provide medical advice --
always follow the guidance of your pharmacist, physician, or the recalling company for any medication you take.
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