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.
- 2016-05-18FDA-DrugSesderma, SLClass IIScreenses Color Sunscreen Tinted facial make-up compact, Broad Spectrum SPF 50, Brown, 0.35 oz (10 g), Manufactured by Sesderma S.L., Valencia, Spain, UPC 8 429979 252166
cGMP Deviations; product does not comply with cGMP requirements
- 2016-05-18FDA-DrugSesderma, SLClass IIRepaskin 30 (octacrylene 4%, oxybenzone 3%, octisalate 3%, octinoxate 3% Avobenzone 3%) Facial Sunscreen gel cream, Broad Spectrum SPF 30, 1.7 fl oz (50 mL) bottle, over the counter, Manufactured by Sesderma S.L., Valencia, Spain, NDC 63181-0010-1
cGMP Deviations; product does not comply with cGMP requirements
- 2016-05-18FDA-DrugSesderma, SLClass IIRepaskin 50 (octocrylene 7%, titanium oxide 2%) Facial Sunscreen gel cream, Broad Spectrum SPF 50, 1.7 fl oz (50 mL) tube, over the counter, Manufactured by Sesderma S.L., Valencia, Spain, NDC 63181-0011-1
cGMP Deviations; product does not comply with cGMP requirements
- 2016-05-18FDA-DrugSesderma, SLClass IIDryses Aluminum Chlorohydrate Deodorant for Women, Roll-on, 2.5 fl oz (75 mL) bottle, over the counter, Manufactured by Sesderma S.L., Valencia, Spain, NDC 16047-0029-1
cGMP Deviations; product does not comply with cGMP requirements
- 2016-05-18FDA-DrugSesderma, SLClass IIDryses Aluminum Chlorohydrate Deodorant for Men Roll-on, 2.5 fl oz (75 mL) bottle, over the counter, Manufactured by Sesderma S.L., Valencia, Spain, NDC 63181-0019-1 UPC 8 470002 075221
cGMP Deviations; product does not comply with cGMP requirements
- 2016-05-18FDA-DrugSesderma, SLClass IIRepaskin 30 (octacrylene 4%, oxybenzone 3%, octisalate 3%, octinoxate 3% Avobenzone 3%) Body Lotion Sunscreen gel cream, Broad Spectrum SPF 30, 6.8 fl oz (200 mL) tube, over the counter, Manufactured by Sesderma S.L., Valencia, Spain, NDC 63181-0012-1 UPC8 429979 415691
cGMP Deviations; product does not comply with cGMP requirements
- 2016-05-18FDA-DrugSesderma, SLClass IIRepaskin 50 (octocrylene 7%, titanium dioxide 2%) Body Lotion Sunscreen gel cream, Broad Spectrum SPF 50, 6.8 fl oz (200 mL) tube, over the counter, Manufactured by Sesderma S.L., Valencia, Spain, NDC 63181-0013-1, UPC 8 429979 415707
cGMP Deviations; product does not comply with cGMP requirements
- 2016-05-18FDA-DrugSesderma, SLClass IISalises Facial Moisturizing Acne Treatment Gel, (salicylic acid 1.5%), 1.7 fl. oz (50 mL) bottle, over the counter, Manufactured by Sesderma S.L., Valencia, Spain --- NDC 63181-0016
cGMP Deviations; product does not comply with cGMP requirements
- 2016-05-18FDA-DrugSesderma, SLClass IIDryses Aluminum Chlorohydrate Antiperspirant Solution, 3.4 fl. oz (100 mL) bottle, over the counter, Manufactured by Sesderma S.L., Valencia, Spain, NDC 63181-0015-1, UPC 8 470003 244268
cGMP Deviations; product does not comply with cGMP requirements
- 2016-05-18FDA-DrugDr. Reddy's Laboratories, Inc.Class IIOndansetron Tablets USP, 4 mg, 30 count bottles, Rx only, Manufactured by: Dr. Reddy's Laboratories, Bachupally, India --- NDC 56111-153-30
Failed Impurities/Degradation Specifications; 12 month stability time point
- 2016-05-18FDA-DrugMylan Pharmaceuticals Inc.Class IIPaliperidone Extended-release Tablets, 1.5 mg, 30 count bottles, Rx only, Mylan Pharmaceuticals, Inc., Morgantown, WV --- NDC 0378-3978-93
Failed Dissolution Specifications; three month stability time point.
- 2016-05-11FDA-DrugA-S Medication Solutions LLC.Class IIIAcetaminophen & Codeine Phosphate Tablets, 300 mg/30 mg, 15-count plastic bottle, Rx only, Mfr: Aurolife Pharma LLC, Dayton NJ, Packaged Exclusively by: A-S Medication Solutions LLC, Libertyville, ILL 60048, NDC 54569-8305-0
Labeling: Not elsewhere classified - count on the label was incorrect.
- 2016-05-11FDA-DrugVistaPharm, Inc.Class IIOxycodone Hydrochloride Oral Solution, USP 5 mg/5 mL (1mg/ml) (NDC 66689-401-01), shrink- wrapped in 10 unit dose cups x 5 trays per case (NDC 66689-401-50), Rx only, Manufactured by VistaPharm, Largo, FL 33771
Defective Container: Excess lidding material accumulation between the seal and the cup resulting in the lid not properly adhering and allowing leakage.
- 2016-05-11FDA-DrugBryant Ranch Prepack Inc.Class IIIVenlafaxine 75 mg Tablet, Compare to Effexor 75 mg Tablet, a) 30-count bottle (NDC 636290-3324-2), b) 100-count bottle (NDC 63629-3324-6), Rx Only, Manufactured by Teva Pharmaceuticals USA, Inc. Packaged by Bryant Ranch.
Labeling: Label Mix-Up: Bryant Ranch received Tevas venlafaxine hydrochloride extended-release tablets for repackaging, but labeled it incorrectly as the immediate release formulation.
- 2016-05-11FDA-DrugHospira Inc.Class IIIQuelicin (Succinylcholine Chloride) Injection, USP 200 mg. (20 mg/mL), 10 mL Multiple-dose vial, packaged in 25 Unit vials per carton, Rx only, HOSPIRA, INC., LAKE FOREST, IL 60045 USA, NDC 0409-6629-02
Labeling: Incorrect or Missing Lot and/or Exp Date: Potential for the lot number and/or expiration date to be faded or missing from the primary label on the glass vial.
- 2016-05-11FDA-DrugAkorn, Inc.Class IIGood Neighbor Pharmacy PEG-Phen Lubricant Eye Drops (Polyethylene Glycol 400 0.4% / Propylene Glycol 0.3%), 15 ml bottle, Distributed by AmerisourceBergen, 1300 Morris Drive, Chesterbrook, PA 19087, NDC 46122-199-05, ALSO labeled as Premier Value Brand PEG-Phen Lubricant Eye Drops (Polyethylene Glycol 400 0.4% / Propylene Glycol 0.3%), 15 ml bottle, Distributed by Chain Drug Consortium, 3301 NW Boca Raton Blvd, Suite 101, Boca Raton, FL 33431, NDC 68016-0404-00.
Presence of Particulate Matter
- 2016-05-04FDA-DrugMckesson Packaging ServicesClass IIISKY Aspirin Chewable Tablets, 81 mg, Unit Dose 750 tablets (25 x 30) box, OTC, Distributed by: McKesson Packaging Service, Concord, NC 28027, NDC 63739-434-01.
Labeling: Label mix-up -outer carton incorrectly labeled as aspirin chewable tablets.
- 2016-04-27FDA-DrugAbbVie Inc.Class IIIZemplar (paricalcitol) capsules, 1 mcg, 30-count bottle, Rx Only, Mfd for AbbVie Inc. North Chicago, IL 60064, NDC 0074-4317-30.
Failed Content Uniformity Specifications
- 2016-04-27FDA-DrugHospira Inc.Class IIPotassium Chloride Injection 20 mEq, 400 mEq/L, Packaged in 50 mL Bags, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7077-14
Chemical Contamination: Potential for contamination of the products with an aromatic hydrocarbon resin.
- 2016-04-27FDA-DrugHospira Inc.Class IIMannitol I.V., 20%, USP (20 g/ 100 mL), Packaged in 250 mL Bags, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC: 0409-7715-02, Barcode (01) 0 030409 771502 2
Chemical Contamination: Potential for contamination of the products with an aromatic hydrocarbon resin.
- 2016-04-27FDA-DrugHospira Inc.Class IIAminosyn-PF (amino acids) 7%, Sulfite-Free, 500 mL Bags, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC: 0409-4178-03 Barcode (01) 0 030409 417803 5
Chemical Contamination: Potential for contamination of the products with an aromatic hydrocarbon resin.
- 2016-04-27FDA-DrugHospira Inc.Class IIDextrose Injection, USP, 20%, Packaged as 500 mL in 1000 mL Bags, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7935-19, Barcode (01) 0 030409 793519 2
Chemical Contamination: Potential for contamination of the products with an aromatic hydrocarbon resin.
- 2016-04-27FDA-DrugHospira Inc.Class IIDextrose Injection, USP, 50%, Packaged as 500 mL in 1000 mL Bag, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7936-19, Barcode (01) 0 030409 793619 9
Chemical Contamination: Potential for contamination of the products with an aromatic hydrocarbon resin.
- 2016-04-27FDA-DrugHospira Inc.Class IIDextrose Injection, USP, 70%, Packaged as 500 mL in 1000 mL Bag, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7918-19, Barcode (01) 0 030409 791819 5
Chemical Contamination: Potential for contamination of the products with an aromatic hydrocarbon resin.
- 2016-04-27FDA-DrugImpax Laboratories, Inc.Class IIDextroamphetamine Sulfate Tablets USP, 5 mg, 100-count bottle, Rx only, Manufactured and Distributed by: CorePharma, LLC, Middlesex, NJ 08846, NDC 64720-215-10
Failed Impurities/Degradation Specifications
- 2016-04-27FDA-DrugImpax Laboratories, Inc.Class IIDextroamphetamine Sulfate Tablets USP, 10 mg, 100-count bottle, Rx only, Manufactured and Distributed by: Corepharma, LLC, Middlesex, NJ 08846, NDC 64720-0216-10
Failed Impurities/Degradation Specifications
- 2016-04-27FDA-DrugTorrent Pharmaceuticals LimitedClass IIITelmisartan Tablets, USP, 80 mg, 30-count (3 x 10 unit-dose blisters) per carton, Rx only, Manufactured by: Torrent Pharmaceuticals LTD., Indrad-382 721, Dist. Mehsana, INDIA.; For: Torrent Pharma Inc., 150 Allen Road, Suite 102, Basking Ridge, NJ 07920, NDC 13668-158-72, UPC 3 13668 158 72 4.
Presence of Foreign Substance: Product complaint for the presence of foreign matter identified as silicone within the tablet.
- 2016-04-20FDA-DrugAmerisource Health ServicesClass IIIFenofibrate Capsules (Micronized), 200 mg , 30-count Unit Dose Blister Packs per carton, Rx Only, Packaged and Distributed by: American Health Packaging Columbus, Ohio 43217 Carton of 30:NDC 68084-835-32, Individual Dose: NDC 68084-835-33.
Labeling: Incorrect or Missing Lot and/or Exp Date
- 2016-04-20FDA-DrugAmerisource Health ServicesClass IIIFenofibrate Capsules (Micronized), 134 mg Capsules, 20-count Unit Dose Blister Packs per carton, Rx Only, Packaged and Distributed by: American Health Packaging Columbus, Ohio 43217, Carton of 20: NDC 68084-835-32, Individual Dose: NDC 68084-835-33.
Labeling: Incorrect or Missing Lot and/or Exp Date
- 2016-04-20FDA-DrugImpax Laboratories, Inc.Class IIIFenofibrate Capsules (Micronized) 200 mg, 500-count bottle, Rx Only, Distributed by Impax Generics, Hayward, CA 94544, NDC 0115-0533-02
Labeling: Incorrect or Missing Lot and/or Exp. Date
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