Drug and pharmaceutical recalls
17628 federal recalls on file. Federal recalls for prescription drugs, OTC medications, supplements, and pharmaceuticals. Sourced from the FDA and translated into plain English.
- 2016-04-20FDA-DrugImpax Laboratories, Inc.Class IIIFenofibrate Capsules (Micronized) 134 mg, 500-count bottle, Rx Only, Distributed by Impax Generics, Hayward, CA 94544, NDC 0115-0522-02
Labeling: Incorrect or Missing Lot and/or Exp. Date
- 2016-04-20FDA-DrugFresenius Kabi USA, LLCClass IICisatracurium Besylate Injection, 20 mg per 10 mL (2 mg per mL), For intravenous injection, 10 mL Multiple Dose Vial, Rx only, Fresenius Kabi USA, LLC Lake Zurich, IL 60047, NDC 63323-417-10
Incorrect/ Undeclared Excipient: Firm is recalling product due to an incorrect statement of Preservative free on the individual carton label. The vial label and outer carton label contain the correct statement of 0.9% benzyl alcohol added as a preservative.
- 2016-04-20FDA-DrugFresenius Kabi USA, LLCClass IIIHaloperidol Decanoate Injection, 50 mg/mL, 1 mL vial, Rx Only. Fresenius Kabi USA LLC, Lake Zurich, IL 60047, NDC 63323-469-01.
Failed Impurities/Degradation Specifications: Firm is recalling product due to an impurity out-of-specification result.
- 2016-04-20FDA-DrugBiocon IncClass IIISimvastatin Tablets, USP 5 mg Rx only, a) 90 count (NDC 24658-0300-90) and b) 1000 count (NDC 24658-0300-10 )bottles, Manufactured by: Blu Caribe Dorado PR 00646, Manufactured for: Blu Pharmaceuticals Franklin, KY 42134
Subpotent Drug
- 2016-04-13FDA-DrugActavis Elizabeth LLCClass IIDextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Tablets, 5 mg, 100 ct. bottle, Rx Only. Manufactured by: Actavis Elizabeth LLC, Elmora Avenue, Elizabeth, NJ 07207. Distributed by: Actavis, Inc., 80 Columbia Road, Bldg B, Morristown, NJ 07960. NDC: 45963-743-11.
Failed Impurities/Degradation Specifications: Out of specification for impurities.
- 2016-04-13FDA-DrugActavis Elizabeth LLCClass IIDextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Tablets, 30 mg, 100 ct. bottle, Rx Only. Manufactured by: Actavis Elizabeth LLC, Elmora Avenue, Elizabeth, NJ 07207. Distributed by: Actavis, Inc., 80 Columbia Road, Bldg B, Morristown, NJ 07960. NDC: 45963-749-11.
Failed Impurities/Degradation Specifications: Out of specification for impurities.
- 2016-04-13FDA-DrugActavis Elizabeth LLCClass IIDextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Tablets, 20 mg, 100 ct. bottle, Rx Only. Manufactured by: Actavis Elizabeth LLC, Elmora Avenue, Elizabeth, NJ 07207. Distributed by: Actavis, Inc., 80 Columbia Road, Bldg B, Morristown, NJ 07960. NDC: 45963-748-11.
Failed Impurities/Degradation Specifications: Out of specification for impurities.
- 2016-04-13FDA-DrugActavis Elizabeth LLCClass IIDextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Tablets, 10 mg, 100 ct. bottle, Rx Only. Manufactured by: Actavis Elizabeth LLC, Elmora Avenue, Elizabeth, NJ 07207. Distributed by: Actavis, Inc., 80 Columbia Road, Bldg B, Morristown, NJ 07960. NDC: 45963-745-11.
Failed Impurities/Degradation Specifications: Out of specification for impurities.
- 2016-04-13FDA-DrugJubilant Draximage IncClass IIISODIUM IODIDE I 131 CAPSULE, USP DIAGNOSTIC ORAL , Rx only, Manufactured by Jubilant DraxImage, Inc., Kirkland, QC, Canada, NDC 65174-461-05
Labeling: Label Error on Declared Strength
- 2016-04-13FDA-DrugApace KY LLCClass IIIMinocycline Hydrochloride Capsules USP, 100 mg*, 30 Capsules (3 x 10) Unit Dose blisters (NDC 50268-569-11, barcode 5026856911) per carton (NDC 50268-569-13, barcode 5026856913), Rx only, Manufactured for: AvKARE, Inc., Pulaski, TN 38478.
Labeling: Incorrect or Missing Lot and/or Exp Date: the individual blisters are mislabeled with an incorrect lot number of 13560 rather than the correct lot number of 13650.
- 2016-04-13FDA-DrugPurdue Pharma L.P.Class IIIIntermezzo (zolpidem tartrate) sublingual tablet 1.75 mg, CIV, 30 Ct Cartons, Rx Only. Dist by Purdue Pharma L.P., Stamford, CT 06901-3431. NDC: 59011-256-30.
Failed Dissolution Specifications
- 2016-04-13FDA-DrugBio-pharm, Inc.Class IIIRanitidine Syrup (Ranitidine Oral Solution, USP), 15 mg/mL (75 mg/5 mL), 16 fl oz Bottle, Rx only, Mfd For: Heritage Pharmaceuticals Inc., Eatontown, NJ 07724, NDC 23155-291-51
Failed Impurities/Degradation Specifications: Product recalled due to elevated impurity result detected during routine stability testing.
- 2016-04-13FDA-DrugMeditech Laboratories, IncClass IIFormula 2 (Papaverine 9 mg, Phentolamine 1 mg, Atropine 0.1 mg, PGE 10 mcg/mL), 5 mL vials, Meditech Laboratories, Inc., 3200 Polaris Ave., Suite 27, Las Vegas, NV 89102.
Stability Does Not Support Expiry: manufactured with an active ingredient that expired before the labeled Beyond Use Date.
- 2016-04-13FDA-DrugMeditech Laboratories, IncClass IIFormula 0 (PGE 20 mcg/mL) Injection, 5 mL vials, Rx only, Meditech Laboratories, Inc., 3200 Polaris Ave., Suite 27, Las Vegas, NV 89102.
Lack of Assurance of Sterility: incomplete or missing data regarding production.
- 2016-04-13FDA-DrugMeditech Laboratories, IncClass IIFormula 3 (Papaverine 20 mg, Phentolamine 3 mg, Atropine 0.2 mg, PGE 20 mcg/mL) Injection, 5 mL vials, Rx only, Meditech Laboratories, Inc., 3200 Polaris Ave., Suite 27, Las Vegas, NV 89102.
Stability Does Not Support Expiry: manufactured with an active ingredient that expired before the labeled Beyond Use Date.
- 2016-04-13FDA-DrugMeditech Laboratories, IncClass IIFormula 1 (Papaverine 1.8 mg, Phentolamine 0.2 mg, Atropine 0.02 mg, PGE 18 mcg/mL) Injection, 5 mL vial, Rx only, Meditech Laboratories, Inc., 3200 Polaris Ave., Suite 27, Las Vegas, NV 89102.
Stability Does Not Support Expiry: manufactured with an active ingredient that expired before the labeled Beyond Use Date.
- 2016-04-13FDA-DrugMeditech Laboratories, IncClass IIFormula 9 (Papaverine 0.9 mg, Phentolamine 0.1 mg, Atropine 0.01 mg, PGE 20 mcg/mL) Injection, 5 mL vial, Rx only, Meditech Laboratories, Inc., 3200 Polaris Ave., Suite 27, Las Vegas, NV 89102.
Lack of Assurance of Sterility: incomplete or missing data regarding production.
- 2016-04-13FDA-DrugMeditech Laboratories, IncClass IIFormula 4 (Papaverine 18 mg, Phentolamine 2 mg, Atropine 0.2 mg/mL) Injection, 5 mL vials, Rx only, Meditech Laboratories, Inc., 3200 Polaris Ave., Suite 27, Las Vegas, NV 89102. .
Lack of Assurance of Sterility: incomplete or missing data regarding production.
- 2016-04-13FDA-DrugMeditech Laboratories, IncClass IIFormula 2 (Papaverine 9 mg, Phentolamine 1 mg, Atropine 0.1 mg, PGE 10 mcg/mL) Injection, 5 mL vials, Rx only, Meditech Laboratories, Inc., 3200 Polaris Ave., Suite 27, Las Vegas, NV 89102.
Superpotent Drug: one ingredient was found to be above assay specification.
- 2016-04-13FDA-DrugVirtus Pharmaceuticals, LlcClass IIIVP-CH-PNV PRENATAL/POSTNATAL Prescription Folic Acid-Containing Dietary Supplement, 30-count Softgel bottles, Rx, Manufactured for Vitrus Pharmaceuticals, LLC, Tampa, FL 33619, NDC 69543-224-30, UPC 369543224305
Defective Delivery System: Product may contain leaking capsules.
- 2016-04-06FDA-DrugPfizer IncClass IIIAdult Robitussin PEAK COLD Cough & Chest Congestion DM Liquid 8 oz. Bottle (237 mL), Distributed by Pfizer, Madison, NJ 07940, NDC 0031-8736-18
Labeling: Label Mix-Up
- 2016-04-06FDA-DrugGenzyme CorporationClass IIILumizyme (alglucosidase alpha), 50 mg/vial, For Intravenous Infusion Only, Rx Only, Manufactured by Genzyme Corportation, Cambridge, MA 02142, NDC 58468-0160-1
Labeling: Incorrect or Missing Lot and/or Exp Date
- 2016-04-06FDA-DrugWalter's PharmacyClass IITobramycin 14 mg/mL Ophth Solution, 10mL bottle, Rx only, Walter's Pharmacy, 401 N 17th St, Allentown, PA 610-435-4706, NDC 99999-9996-60
Lack of Assurance of Sterility
- 2016-04-06FDA-DrugWalter's PharmacyClass IIVancomycin 50mg/mL Solution, 10mL bottle, Rx only, Walter's Pharmacy, 401 N 17th St, Allentown, PA 610-435-4706, NDC 99999-9991-54
Lack of Assurance of Sterility
- 2016-04-06FDA-DrugWalter's PharmacyClass IILidocaine Nebulizer 1% Solution, Rx only, Walter's Pharmacy, 401 N 17th St, Allentown, PA 610-435-4706, NDC 99999-9020-61
Lack of Assurance of Sterility
- 2016-04-06FDA-DrugWalter's PharmacyClass IIEdetate Disodium 2% Ophth Solution, 15mL bottle, Rx only, Walter's Pharmacy, 401 N 17th St, Allentown, PA 610-435-4706, NDC 99999-9019-47
Lack of Assurance of Sterility
- 2016-04-06FDA-DrugWalter's PharmacyClass IIAcetylcysteine 10% Ophth Solution, 10mL bottle, Rx only, Walter's Pharmacy 401 N 17th St, Allentown, PA 610-435-4706, NDC 99999-9018-33
Lack of Assurance of Sterility
- 2016-04-06FDA-DrugWalter's PharmacyClass IIAtropine 0.01% Ophth Solution, 15mL bottle, Rx only, Walter's Pharmacy 401 N 17th St Allentown, PA 610-435-4706, NDC 99999-9019-09
Lack of Assurance of Sterility
- 2016-04-06FDA-DrugWalter's PharmacyClass IIVancomycin 25mg/mL Solution, 10 mL bottles, Rx only, Walter's Pharmacy 401 N 17th St., Allentown, PA 610-435-4706, NDC 99999-9003-78
Lack of Assurance of Sterility
- 2016-04-06FDA-DrugWalter's PharmacyClass IITobramycin 15mg/mL Ophth Solution, packaged in 5mL and 10mL bottles, Rx only, Walter's Pharmacy 401 N 17th St., Allentown, PA 610-435-4706, NDC 99999-9996-35
Lack of Assurance of Sterility
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