Drug and pharmaceutical recalls
17731 federal recalls on file. Federal recalls for prescription drugs, OTC medications, supplements, and pharmaceuticals. Sourced from the FDA and translated into plain English.
- 2016-09-14FDA-DrugTeva North AmericaClass IIEptifibatide Injection 75 mg/100 mL (0.75 mg/mL) single use vial, For Intravenous Use Only, Rx Only, Manufactured in Hungary for TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454, NDC# 0703-1179-01.
CGMP Deviations
- 2016-09-14FDA-DrugTeva North AmericaClass IILinezolid Injection 600 mg/300 mL Rx Only, Manufactured in Hungary for TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454, NDC# 0703-9060-31- (Single Use Container), NDC# 0703-9060-33 (Box of 10 Singe Use Containers)
CGMP Deviations
- 2016-09-14FDA-DrugTeva North AmericaClass IIARGATROBAN Injection in 0.9% Sodium Chloride 250 mg/250 mL (1 mg/mL) , Rx Only, Manufactured in Hungary for TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454, NDC# 0703-0020-31 (Single Use Bag), NDC # 0703-0020-32 (5 Single Use Bags in One Carton).
CGMP Deviations
- 2016-09-14FDA-DrugLupin LimitedClass IIIAmlodipine Besylate Tablets USP, 10mg, 1000-count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, Manufactured by: Lupin Limited Goa 403 722 INDIA, NDC 68180-752-03
CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.
- 2016-09-14FDA-DrugLupin LimitedClass IIIAmlodipine Besylate Tablets USP, 2.5mg, 90-count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, Manufactured by: Lupin Limited Goa 403 722 INDIA, NDC 68180-750-09
CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.
- 2016-09-14FDA-DrugZydus Pharmaceuticals USA IncClass IIBromocriptine Mesylate Capsules USP, 5 mg, 30-count bottles, Rx only, Manufactured by: Cadila Healthcare ltd., Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA Inc., Pennington, NJ 08534, NDC 68382-110-06
Failed impurities/degradation specifications: Out of specification results noticed in related substance test during analysis of 24 months long term (25 degree Celsius /65% RH) stability samples of two batches.
- 2016-09-14FDA-DrugAmerisource Health ServicesClass IIDextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate (Mixed Salts of a Single-Entity Amphetamine Product) Extended-Release Capsules CII 30 mg 20 UD Capsules (5 x 4), Rx, Packaged and Distributed by: American Health Packaging, Columbus, OH ---- Carton NDC 68084-887-32; Blister NDC 68084-887-33
Unit Dose Mispackaging; blister cavities may contain more than one tablet /capsule
- 2016-09-14FDA-DrugAmerisource Health ServicesClass IIDextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate (Mixed Salts of a Single-Entity Amphetamine Product) Extended-Release Capsules CII 25 mg 20 UD Capsules (5 x 4), Rx, Packaged and Distributed by: American Health Packaging, Columbus, OH ---- Carton NDC 68084-909-32; Blister NDC 68084-909-33
Unit Dose Mispackaging; blister cavities may contain more than one tablet /capsule
- 2016-09-14FDA-DrugAmerisource Health ServicesClass IIDextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate (Mixed Salts of a Single-Entity Amphetamine Product) Extended-Release Capsules, CII 20 mg, 30 UD Capsules (5 x 6), Rx, Packaged and Distributed by: American Health Packaging, Columbus, OH --- Carton NDC 68084-832-25; Blister NDC 68084-832-95
Unit Dose Mispackaging; blister cavities may contain more than one tablet /capsule
- 2016-09-14FDA-DrugAmerisource Health ServicesClass IIDextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate (Mixed Salts of a Single-Entity Amphetamine Product) Extended-Release Capsules CII 15 mg 20 UD Capsules (5 x 4), Rx, Packaged and Distributed by: American Health Packaging, Columbus, OH --- Carton NDC 68084-898-32; Blister NDC 68084-898-33
Unit Dose Mispackaging; blister cavities may contain more than one tablet /capsule
- 2016-09-14FDA-DrugAmerisource Health ServicesClass IIDextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate (Mixed Salts of a Single-Entity Amphetamine Product) Extended-Release Capsules CII 10 mg 30 UD Capsules (5 x 6), Rx, Packaged and Distributed by: American Health Packaging, Columbus, OH --- Carton NDC 68084-815-25; Blister NDC 68084-815-95
Unit Dose Mispackaging; blister cavities may contain more than one tablet /capsule
- 2016-09-14FDA-DrugAmerisource Health ServicesClass IIDextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Tablets (Mixed Salts of a Single Entity Amphetamine Product) CII 30 mg, 30 UD Tablets (5 x 6), Rx, Packaged and Distributed by: American Health Packaging, Columbus, OH --- Carton NDC 60687-154-25; Blister NDC 60687-154-95
Unit Dose Mispackaging; blister cavities may contain more than one tablet /capsule
- 2016-09-14FDA-DrugAmerisource Health ServicesClass IIDextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Tablets (Mixed Salts of a Single Entity Amphetamine Product) CII 20 mg, 30 UD Tablets (5 x 6), Rx, Packaged and Distributed by: American Health Packaging, Columbus, OH --- Carton NDC 68084-943-25; Blister NDC 68084-943-95
Unit Dose Mispackaging; blister cavities may contain more than one tablet /capsule
- 2016-09-14FDA-DrugAmerisource Health ServicesClass IIDextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Tablets (Mixed Salts of a Single Entity Amphetamine Product) CII 15 mg, 30 UD Tablets (5 x 6), Rx, Packaged and Distributed by: American Health Packaging, Columbus, OH ---- Carton NDC 60687-133-25; Blister NDC 60687-133-95
Unit Dose Mispackaging; blister cavities may contain more than one tablet /capsule
- 2016-09-14FDA-DrugAmerisource Health ServicesClass IIDextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Tablets (Mixed Salts of a Single Entity Amphetamine Product) CII 10 mg, 30 UD Tablets (5 x 6), Rx, Packaged and Distributed by: American Health Packaging, Columbus, OH ---- Carton NDC 68084-936-25; Blister NDC 68084-936-95
Unit Dose Mispackaging; blister cavities may contain more than one tablet /capsule
- 2016-09-14FDA-DrugAmerisource Health ServicesClass IIDextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Tablets (Mixed Salts of a Single Entity Amphetamine Product) CII 5 mg, 30 UD Tablets (5 x 6), Rx, Packaged and Distributed by: American Health Packaging, Columbus, OH --- Carton NDC 68084-874-25; Blister NDC 68084-874-95
Unit Dose Mispackaging; blister cavities may contain more than one tablet /capsule
- 2016-09-14FDA-DrugIsomeric Pharmacy Solution, LLCClass IIMethylprednisolone Acetate/Lidocaine HCl 40/10 mg/mL Injection, 10 mL multidose vial, sterile. Rx only. Compounded by Isomeric Pharmacy Solutions, Salt Lake City, UT 84109,
Lack of Processing Controls: Isomeric Pharmacy Solution, LLC announces a voluntary field action for the Methylprednisolone Acetate/Lidocaine HCl 40/10 mg/mL Injection because the sterile injectable products were sterilized too long leading to potential difficulty resuspending particles.
- 2016-09-14FDA-DrugStason Pharmaceuticals, Inc.Class IIISelegiline HCL Tablets USP 5mg, 60- count bottles, Rx only, Manufactured by: Stason Pharmaceuticals, Inc. Irvine, CA 92618 Distributed by: Libertas Pharma, Inc. Montgomery, AL 36117. NDC 51862-146-06
Stason Pharmaceuticals is recalling Selegiline HCl tablets, USP 5mg 60 count bottle due to an out of specification result for dissolution of stability samples.
- 2016-09-07FDA-DrugClinique InternationalClass IIICLINIQUE moisture surge tinted moisturizer broad spectrum SPF 15, 1 FL. OZ.LIQ./30 ml bottle within a carton, Clinique Labs., Dist. New York, N.Y., 10022; New York, London W1K 3BQ; Paris, UPC No. 20714-48241-1, Shade 06 (D-G)
Subpotent Drug: Two of the active sunscreen ingredients, octinoxate and octisalate, are below the specifications for assay.
- 2016-09-07FDA-DrugClinique InternationalClass IIICLINIQUE moisture surge tinted moisturizer broad spectrum SPF 15, 1 FL. OZ.LIQ./30 ml bottle within a carton, Clinique Labs., Dist. New York, N.Y., 10022; New York, London W1K 3BQ; Paris, UPC No. 20714-48240-4, Shade 05 (D-G)
Subpotent Drug: Two of the active sunscreen ingredients, octinoxate and octisalate, are below the specifications for assay.
- 2016-09-07FDA-DrugClinique InternationalClass IIICLINIQUE moisture surge tinted moisturizer broad spectrum SPF 15, 1 FL. OZ.LIQ./30 ml bottle within a carton, Clinique Labs., Dist. New York, N.Y., 10022; New York, London W1K 3BQ; Paris, UPC No. 20714-47479-9, Shade 04 (M-N)
Subpotent Drug: Two of the active sunscreen ingredients, octinoxate and octisalate, are below the specifications for assay.
- 2016-09-07FDA-DrugClinique InternationalClass IIICLINIQUE moisture surge tinted moisturizer broad spectrum SPF 15, 1 FL. OZ.LIQ./30 ml bottle within a carton, Clinique Labs., Dist. New York, N.Y., 10022; New York, London W1K 3BQ; Paris, UPC No. 20714-47478-2, Shade 03 (MF-N)
Subpotent Drug: Two of the active sunscreen ingredients, octinoxate and octisalate, are below the specifications for assay.
- 2016-09-07FDA-DrugClinique InternationalClass IIICLINIQUE moisture surge tinted moisturizer broad spectrum SPF 15, 1 FL. OZ.LIQ./30 ml bottle within a carton, Clinique Labs., Dist. New York, N.Y., 10022; New York, London W1K 3BQ; Paris, UPC No. 20714-47477-5, Shade 02 (VF-N)
Subpotent Drug: Two of the active sunscreen ingredients, octinoxate and octisalate, are below the specifications for assay.
- 2016-09-07FDA-DrugClinique InternationalClass IIICLINIQUE moisture surge tinted moisturizer broad spectrum SPF 15, 1 FL. OZ.LIQ./30 ml bottle within a carton, Clinique Labs., Dist. New York, N.Y., 10022; New York, London W1K 3BQ; Paris, UPC No. 20714-47476-8, Shade 01 (VF-N)
Subpotent Drug: Two of the active sunscreen ingredients, octinoxate and octisalate, are below the specifications for assay.
- 2016-08-31FDA-DrugActavis IncClass IIIHydrocortisone and acetic acid otic solution, Rx only, 10 mL bottle, Distributed by Actavis Inc. 60 Columbia Road Bldg B. Morristown, NJ 07560 USA , NDC 45963-412-61
Failed Impurities/Degradation Specifications: Out of specification (OOS) results for related compound G were obtained at 12-month (at expiry) stability time-point for room temperature sample(s).
- 2016-08-31FDA-DrugActavis IncClass IIIAcetasol HC (hydrocortisone and acetic acid otic solution USP) , Rx Only, 10 mL bottle, Manufactured by: Actavis Midatlantic LLC 1877 Kawai Road Lincolnton, NJ 28092 USA, NDC 0472-0882-82
Failed Impurities/Degradation Specifications: Out of specification (OOS) results for related compound G were obtained at 12-month (at expiry) stability time-point for room temperature sample(s).
- 2016-08-31FDA-DrugTeva North AmericaClass IIAmoxicillin for Oral Suspension USP, 400 mg/ 5 mL, 50 mL bottle, Rx only, Manufactured In Canada by: Teva Canada Limited, Toronto, Canada, NDC 0093-4161-76
Superpotent drug: Out of specification test result for assay during stability testing.
- 2016-08-31FDA-DrugAkorn, Inc.Class IIIDesoximetasone Gel USP, 0.05%, packaged in 60 gram aluminum tubes, Rx only, Marketed by: VersaPharm Incorporated Marietta, GA 30062, Manufactured by: Ei LLC Kannapolis, NC 28083, NDC 61748-205-60.
Failed impurities/degradation specifications: product was out of specification for unknown impurity at the 9 month stability time point
- 2016-08-31FDA-DrugMylan Institutional, Inc. (d.b.a. UDL Laboratories)Class IIAmlodipine Besylate Tablets, USP, 10 mg*, packaged in a) 100-count (10 x 10) unit dose blisters per carton, NDC 51079-452-20; b) 300-count (10 x 30) unit dose blisters per carton, NDC 51079-452-56; and c) 25-count (25 x 1) Robot-Rx Ready Packages in a carton, NDC 51079-452-19; Rx only, Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV 26505; Packaged and Distributed By: UDL Laboratories, Inc., Rockford, IL 61103.
CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices.
- 2016-08-31FDA-DrugMylan Institutional, Inc. (d.b.a. UDL Laboratories)Class IIAmlodipine Besylate Tablets, USP, 5 mg*, packaged in a) 100-count (10 x 10) unit dose blisters per carton, NDC 51079-451-20; b) 300-count (10 x 30) unit dose blisters per carton, NDC 51079-451-56, c) 25-count (25 x 1) Robot-Rx Ready Packages in a carton, NDC 51079-451-19; and d) 30-count tablets per dosage card in a carton, NDC 51079-451-69, Rx only, Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV 26505; Packaged and Distributed By: UDL Laboratories, Inc., Rockford, IL 61103.
CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices.
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