Drug and pharmaceutical recalls
17747 federal recalls on file. Federal recalls for prescription drugs, OTC medications, supplements, and pharmaceuticals. Sourced from the FDA and translated into plain English.
- 2015-01-28FDA-DrugWalgreens Infusion ServicesClass IITigecycline various strengths in normal saline
Lack of sterility assurance.
- 2015-01-28FDA-DrugWalgreens Infusion ServicesClass IILinezolid various strengths in dextrose
Lack of sterility assurance.
- 2015-01-28FDA-DrugWalgreens Infusion ServicesClass IILevofloxacin various strengths in normal saline
Lack of sterility assurance.
- 2015-01-28FDA-DrugWalgreens Infusion ServicesClass IICeftriaxone various strengths in normal saline
Lack of sterility assurance.
- 2015-01-28FDA-DrugWalgreens Infusion ServicesClass IIDaptomycin various strengths in normal saline bags
Lack of sterility assurance.
- 2015-01-28FDA-DrugWalgreens Infusion ServicesClass IIGentamicin various strength in normal saline bags
Lack of sterility assurance.
- 2015-01-28FDA-DrugWalgreens Infusion ServicesClass IITobramycin various strengths in normal saline bags
Lack of sterility assurance.
- 2015-01-28FDA-DrugWalgreens Infusion ServicesClass IICefazolin various strengths in normal saline bags
Lack of sterility assurance.
- 2015-01-28FDA-DrugWalgreens Infusion ServicesClass IINafcillin various strengths in sterile water for injection bags
Lack of sterility assurance.
- 2015-01-28FDA-DrugWalgreens Infusion ServicesClass IIMeropenem various strengths in normal saline bags
Lack of sterility assurance.
- 2015-01-28FDA-DrugWalgreens Infusion ServicesClass IICefuroxime various strengths in normal saline bags
Lack of sterility assurance.
- 2015-01-28FDA-DrugWalgreens Infusion ServicesClass IIVancomycin various strengths in normal saline bags
Lack of sterility assurance.
- 2015-01-28FDA-DrugWalgreens Infusion ServicesClass IIPiperacillin/ tazobactam various strength in normal saline bags
Lack of sterility assurance.
- 2015-01-28FDA-DrugWalgreens Infusion ServicesClass IIErtapenem various strength in normal saline bags
Lack of sterility assurance.
- 2015-01-28FDA-DrugWalgreens Infusion ServicesClass IIImipenem/ cilastatin various strength in normal saline bags
Lack of sterility assurance.
- 2015-01-28FDA-DrugWalgreens Infusion ServicesClass IICeftazidime various strength in normal saline bags
Lack of sterility assurance.
- 2015-01-28FDA-DrugWalgreens Infusion ServicesClass IICefoxitin various strength in normal saline bags
Lack of sterility assurance.
- 2015-01-28FDA-DrugWalgreens Infusion ServicesClass IICefepime various strengths in normal saline
Lack of sterility assurance.
- 2015-01-28FDA-DrugWalgreens Infusion ServicesClass IIAztreonam 1 gram in normal saline
Lack of sterility assurance.
- 2015-01-28FDA-DrugWalgreens Infusion ServicesClass IIAmikacin various strength in normal saline bags
Lack of sterility assurance.
- 2015-01-28FDA-DrugWalgreens Infusion ServicesClass IILiposomal Amphotericin B 130 mg in dextrose bags
Lack of sterility assurance.
- 2015-01-21FDA-DrugSCA PharmaceuticalsClass IIGlycopyrrolate injection, 0.2 mg per mL (1 mg/5 mL), 5 mL Fill in 10 mL Syringe, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct, Little Rock, AR 72205, 877-550-5059
Labeling: Incorrect or missing Lot and/or Exp Date: Printing error caused an overlap in the "y" and "3" making the actual "Use By 3/2015" date appear to read "Use By8/2015".
- 2015-01-14FDA-DrugActavis Elizabeth LLCClass IIGabapentin Capsules, USP, 100 mg, Rx Only, a) 100 capsules per bottle, NDC 45963-555-11, b) 500 Capsules per bottle, NDC 45963-555-50, Manufactured by: Actavis Pharma Manufacturing Pvt. Ltd., Plot No 101, 102, 107, & 108, SIDCO Pharmaceutical Complex, Alathurt, Kanchipuram Dist-603 110, Tamlinadu, India, Distributed by: Actavis Elizabeth LLC, 700 Elmora Ave, Elizabeth, NJ 07207 USA.
Failed Capsule/Tablet Specifications: Actavis has received several complaint for clumping and breaking of capsules with some bottles showing popped out bottle bottom (round bottom) and creased labels from one distribution center.
- 2015-01-14FDA-DrugActavis Elizabeth LLCClass IIGabapentin Capsules, USP, 300 mg, Rx Only, 100 capsules per bottle, Manufactured by: Actavis Pharma Manufacturing Pvt. Ltd., Plot No 101, 102, 107, & 108, SIDCO Pharmaceutical Complex, Alathurt, Kanchipuram Dist-603 110, Tamlinadu, India, Distributed by: Actavis Elizabeth LLC, 700 Elmora Ave, Elizabeth, NJ 07207 USA, NDC 45963-556-11
Failed Capsule/Tablet Specifications: Actavis has received several complaint for clumping and breaking of capsules with some bottles showing popped out bottle bottom (round bottom) and creased labels from one distribution center.
- 2015-01-14FDA-DrugActavis Elizabeth LLCClass IIGabapentin Capsules, USP, 400 mg, Rx Only, a) 100 capsules per bottle, NDC 14550-513-02, b) 500 Capsules per bottle, NDC 45963-557-50, Manufactured by: Actavis Pharma Manufacturing Pvt. Ltd., Plot No 101, 102, 107, & 108, SIDCO Pharmaceutical Complex, Alathurt, Kanchipuram Dist-603 110, Tamlinadu, India, Distributed by: Actavis Elizabeth LLC, 700 Elmora Ave, Elizabeth, NJ 07207 USA.
Failed Capsule/Tablet Specifications: Actavis has received several complaint for clumping and breaking of capsules with some bottles showing popped out bottle bottom (round bottom) and creased labels from one distribution center.
- 2015-01-14FDA-DrugRight Value Drug Stores, Inc.Class IIGlutathione 200 mg/mL Injectable, packaged in a) 5 mL MDV (multiple dose vials), b) 30 mL MDV (multiple dose vials), and c) 100 mL MDV (multiple dose vials), Rx only, Carie Boyd's Prescription Shop, 122 Grapevine Highway, Hurst, TX 76054, (817) 282-9376.
Incorrect Product Formulation: An incorrect gas was used to remove the oxygen from the vial.
- 2015-01-14FDA-DrugHospira Inc.Class II0.9% Sodium Chloride Injection, USP, 100mL, VisIV Container, Rx only, Hospira Inc., Lake Forest, IL 60045, NDC 0409-7984-11
Lack of Assurance of Sterility: The product has the potential for solution to leak at the administrative port.
- 2015-01-14FDA-DrugAkorn, Inc.Class IIITriamcinolone Acetonide Lotion USP, 0.025% is supplied in the following size: 60 mL (NDC 61748-219-60).
Failed Impurities/Degradation Specifications: The known impurity went out of specification at 12 months stability point.
- 2015-01-14FDA-DrugPar Pharmaceutical Inc.Class IIHydrALAZINE Hydrochloride Tablets, USP 25 mg, 100 count bottle Rx only, Distributed by: Par Pharmaceutical Companies, Inc. Spring Valley, NY10977
Presence of Foreign Substance: Par Pharmaceutical, Inc. is recalling one lot of HydrALAZINE Hydrochloride tablets due to the presence of small aluminum particles.
- 2015-01-14FDA-DrugQualitest PharmaceuticalsClass IIIACETAMINOPHEN and CODEINE PHOSPHATE ORAL SOLUTION USP, 120 mg/12 mg per 5 mL, packaged in a) 4 oz. (120 mL) bottles, NDC 0603-9013-54, UPC 3 0603-9013-54 8 and b) ONE PINT (473 mL) bottles, NDC 0603-9013-58, UPC 3 0603-9013-58 6, Rx only, Manufactured for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811
Failed Impurities/Degradation Specifications: High out of specification results for the known impurity p-Aminophenol.
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