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.
- 2014-10-29FDA-DrugQualitest PharmaceuticalsClass IICHILDREN'S Q-PAP, Acetaminophen, ORAL SUSPENSION, BUBBLE GUM FLAVOR, Active ingredient (in each 5 mL = 1 tsp) Acetaminophen USP 160 mg, 4 FL OZ (118 mL), Made in the USA for Qualitest Pharmaceuticals, Huntsville, AL 35811, NDC 0603-0841-54, OTC
Superpotent Drug: Qualitest Pharmaceuticals is initiating a recall of three flavors of Acetaminophen Oral Suspension Liquid 160mg/5mL for failure of the product assay at the 12 month timepoint.
- 2014-10-29FDA-DrugForest Pharmaceuticals IncClass IIBystolic (nebivolol) tablets, 20 mg/tablet, packaged as 7 tablets/bottle/carton, and 12 bottles/trays, Professional Sample, Rx only, Forest Pharmaceuticals, Inc., St. Louis, MO. --- NDC 0456-1420-07
Failed Dissolution Specification; at the 6-month stability time point
- 2014-10-29FDA-DrugBio-pharm, Inc.Class IIRugby Children's Pain and Fever Acetaminophen Oral Suspension 160 mg/5 mL, Cherry Flavor, 2 FL. oz bottle, OTC, Distributed by: Rugby Laboratories Livonia, MI 48150, NDC 0536-3606-96 Major Children's Mapap Suspension Liquid, Cherry Flavor, 4 FL OZ bottle, OTC, Distributed by: Major Pharmaceuticals Livonia, MI 48150 , NDC 0904-6308-20,
Superpotent Drug: Bio-Pharm, Inc. is initiating a recall of one lot of Acetaminophen Oral Suspension Liquid 160mg/5mL failure of the product assay at the 6 month timepoint.
- 2014-10-22FDA-DrugSagent Pharmaceuticals IncClass IIKetorolac Tromethamine INJECTION, USP, 30 mg per mL, a) 1 mL vial (NDC 25021-701-01) b) 2 mL vial (NDC 25021-701-02), Rx only, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195
Incorrect or Missing Lot and/or Exp Date: Ketorolac Tromethamine Injection, is being recalled as a result of labeling the product with the incorrect expiration date.
- 2014-10-22FDA-DrugValeant Pharmaceuticals InternationalClass IIILocoid (hydrocortisone butyrate 0.1%), Cream, Net Wt. 15 gm tubes, Rx only, Manufactured for: Onset Dermatologics, LLC, Cumberland, RI 02864 By: Ferndale Laboratories, Inc. Ferndale, MI 48220 --- NDC 16781-382-15
Subpotent Drug; for the active, HCB, and preservatives, Propylparaben and Butylparaben at the 18 month stability test point
- 2014-10-22FDA-DrugValeant Pharmaceuticals InternationalClass IIIHydrocortisone Butyrate Cream 0.1%, Net Wt. 15 gm tubes, Rx only, Manufactured for: Rouses Point Pharmaceuticals, LLC Cranford, NJ 07016 By: Ferndale Laboratories, Inc. Ferndale, MI 48220 --- NDC 43478-270-15
Subpotent Drug; for the active, HCB, and preservatives, Propylparaben and Butylparaben at the 18 month stability test point
- 2014-10-22FDA-DrugGyma Laboratories Of Amer,IncClass IIClonidine HCL, 97 Kg, Rx Only, S.I.M.S. , Chemical Product for Medicines Preparation, Made in Italy, NDC 012660-0002
cGMP Deviations: GYMA laboratories Inc. has recalled multiple Active Pharmaceutical Ingredients manufactured in Italy upon receipt of a Rapid Alert Notification issued by The Italian Medicines Agency due to lack of good manufacturing practices.
- 2014-10-22FDA-DrugGyma Laboratories Of Amer,IncClass IIClonidine Base Micronized, 55.8 Kg, Rx Only, S.I.M.S. , Chemical Product for Medicines Preparation, Made in Italy, NDC 12660-0503-01
cGMP Deviations: GYMA laboratories Inc. has recalled multiple Active Pharmaceutical Ingredients manufactured in Italy upon receipt of a Rapid Alert Notification issued by The Italian Medicines Agency due to lack of good manufacturing practices.
- 2014-10-22FDA-DrugGyma Laboratories Of Amer,IncClass IIPropranolol HCl, NET WT 1 Kg, Rx Only, S.I.M.S. , Chemical Product for Medicines Preparation, Made in Italy, NDC 012660-0004
cGMP Deviations: GYMA laboratories Inc. has recalled multiple Active Pharmaceutical Ingredients manufactured in Italy upon receipt of a Rapid Alert Notification issued by The Italian Medicines Agency due to lack of good manufacturing practices.
- 2014-10-22FDA-DrugGyma Laboratories Of Amer,IncClass IIDipyridamole API, NET WT 10 Kg, Rx Only, S.I.M.S. , Chemical Product for Medicines Preparation, Made in Italy, NDC 012660-0084
cGMP Deviations: GYMA laboratories Inc. has recalled multiple Active Pharmaceutical Ingredients manufactured in Italy upon receipt of a Rapid Alert Notification issued by The Italian Medicines Agency due to lack of good manufacturing practices.
- 2014-10-22FDA-DrugHospira Inc.Class ILidocaine HCl Injection, USP, 2%, 20 mg per mL, Preservative-Free, 5 mL Single-Dose Vial, Rx only, For Infiltration and Nerve Block including Epidural and Caudal, Manufactured by: Hospira, Inc., Lake Forest, IL, 60045, NDC 0409-2066-05
Presence of Particulate Matter: The product was discolored and contained visible particulates (iron oxide) in the solution and embedded in the glass vial.
- 2014-10-22FDA-DrugValeant Pharmaceuticals North America LLCClass IIIVasotec (enalapril maleate) tablets, RX only, Manufactured by Valeant Pharmaceuticals International, Inc., Steinbach, MD R5G 1Z7 Canada 2.5 mg 90 ct - NDC 0187-0140-90 5 mg 30 ct - NDC 0187-0141-30 5 mg 90 ct - NDC 0187-0141-90 10 mg 30 ct - NDC 0187-0142-30 10 mg 90 ct - NDC 0187-0142-90 10 mg 1000 ct - NDC 0187-0142-10 20 mg 30 ct - NDC 0187-0143-30 20 mg 90 ct - NDC 0187-0143-90 20 mg 1000 ct - NDC 0187-0143-10 NDC #'s 64455-140, 64455-141, 64455-142
Labeling: Incorrect or Missing Package Insert: Product is packaged with the incorrect version of the package insert.
- 2014-10-22FDA-DrugValeant Pharmaceuticals North America LLCClass IIIVaseretic (enalapril maleate/hydrochlorothiazide) 10/25 mg Tablets, NDC 0187-0146-01, 100 ct. bottles manufactured at Valeant Pharmaceuticals International, Inc., Steinbach, MD R5G 1Z7 Canada
Labeling: Incorrect or Missing Package Insert: Product is packaged with the incorrect version of the package outset
- 2014-10-22FDA-DrugUnit Dose Solutions IncClass IIAtorvastatin Calcium 40 MG Tablet, MFG: Apotex NDC# 6050525808
Presence of Foreign Tablets/Capsules:179 doses of Valacyclovir HCl 500 mg tablets were repacked in unit dose packslabeled as Atorvastatin Calcium
- 2014-10-22FDA-DrugAvella of Deer Valley, Inc.Class IIHYDROXYPROGESTERONE CAPROATE 250 MG/ML (IN SESAME OIL), Rx Only 4 mL INJECTABLE IM USE. Manufactured by Avella Specialty Pharmacy, Phoenix, AZ 85085.
Crystallization: Formation of crystals observed in product.
- 2014-10-22FDA-DrugZydus Pharmaceuticals USA IncClass IITOPIRAMATE Tablets 200 mg, 60 Tablet Bottles, Rx Only. Manufactured by Cadila Healthcare Ltd. Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ USA 08534. NDC 68382-141-14.
Presence of Foreign Tablets: Presence of topiramate 100 mg tablets comingled with 200 mg tablets.
- 2014-10-15FDA-DrugBracco Diagnostic IncClass IIIE-Z- GAS II EFFERVESCENT GRANULES Antacid/Antiflatulent ,4 g (0.14 oz), 50 -count box, Rx Only, Manufactured in USA for E-Z EM, Inc. Lake Success, NY 11042 by Tower Laboratories LTD Centerbrook, CT 06409 NDC 10361-793-01
Subpotent Drug: Out of Specification (OOS) result during routine stability testing at 24 months.
- 2014-10-15FDA-DrugGilead Sciences, Inc.Class IIITruvada (200 mg emtricitabine and 300 mg tenofovir disoproxil fumarate) tablets, 30 count bottles, Rx only, Manufactured for Gilead Sciences, Inc. Foster City, CA 94404, NDC 61958-0701-1
Presence of Foreign Substance: Truvada was found to contain small red silicone rubber particulates.
- 2014-10-15FDA-DrugUnique Pharmaceutical, LtdClass IIAll sterile products within expiry
Lack of Sterility Assurance: A recent FDA inspection revealed poor aseptic production practices that result in lack of sterility assurance of products intended to be sterile.
- 2014-10-15FDA-DrugUnique Pharmaceutical, LtdClass IN-Acetyl Cysteine 20% 4 mL Vial Stock Code: 4133
Non-Sterility: One lot of N-Acetyl Cysteine vials tested positive for Herbaspirillum huttiense.
- 2014-10-15FDA-DrugVistaPharm, Inc.Class IIMETOCLOPRAMIDE ORAL SOLUTION, USP 5 mg/5 mL, (present as the hydrochloride), 10 mL cups, Rx only. Manufactured by VistaPharm Inc., Largo, FL 33771. NDC 66689-031-01.
Defective Container: Product leaks when inverted.
- 2014-10-15FDA-DrugMylan Pharmaceuticals Inc.Class IIMetoprolol Succinate Extended-release Tablets, USP 50mg, 90-count Bottles, Rx only, Mfg by Mylan Pharmaceuticals, Inc. Morgantown, WV 26505. NDC 0378-4596-77.
Presence of Foreign Tablets/Capsules: A pharmacist reported a rogue tablet of different size and markings in bottle of Metoprolol
- 2014-10-15FDA-DrugAstellas Pharma US IncClass IITarceva (erlotinib) Tablets, 150 mg, 30 count bottle, Rx only, Manufactured by: Kremers Urban Pharmaceuticals Inc. Seymour, IN 47274 NDC 50242-064-01
Failed Dissolution Specifications: The product did not meet the acceptance criteria for the dissolution test during the 24 month routine stability testing.
- 2014-10-15FDA-DrugZydus Pharmaceuticals USA IncClass IIZyGenerics ATENOLOL Tablets, USP 25 mg 1000 count bottle, Rx Only Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08634 USA NDC 68382-022-01
Superpotent Drug: A complaint was reported by a pharmacist who stated several tablets were noticeably thicker in appearance.
- 2014-10-15FDA-DrugJanssen Ortho L.L.C.Class IIXarelto (rivaroxaban) Tablets 15 mg per tablet, 5 count bottle, Rx Only, Manufactured by: JOLLC, Gurabo, PR 00778 NDC 50458-578-99
Microbial Contamination of Non-Sterile Products: Consumer complaint confirmed microbial contamination in sales sample.
- 2014-10-15FDA-DrugMckessonClass IIAmiodarone HCl Injection, 450 mg/9 mL (50 mg per mL), 9 mL Single-Use Vial, Rx only, Manufactured for Mylan Institutional, LLC, Rockford, IL 61103, NDC 67457-153-09.
Temperature Abuse: One shipment was inadvertantly stored refrigerated rather than the labeled room temperature recommendation at McKesson Medical-Surgical Inc., one of the distributing wholesalers.
- 2014-10-08FDA-DrugEugene Oregon, Inc.Class IAFRICAN BLACK ANT, 2800 mg, 6 capsules per box, produced by: Qinghan Hongwei Bioengineering Company, No. 158, Renmin Road, Xining City.
Marketed Without an Approved NDA/ANDA: Eugene FDA laboratory analyses determined they contain undeclared sildenafil.
- 2014-10-08FDA-DrugActavis Laboratories, FL, Inc.Class IIDiclofenac Sodium and Misoprostol Delayed-Release Tablets, 50 mg/0.2 mg, 60-count bottle, Rx only, Manufactured by: Watson Laboratories, Inc., Corona, CA 92880, NDC 0591-0397-60, UPC 3 05910 39760 9.
Failed Tablet/Capsule Specifications: Recall due to complaints of split or broken tablets.
- 2014-10-08FDA-DrugActavis Laboratories, FL, Inc.Class IIDiclofenac Sodium and Misoprostol Delayed-Release Tablets, 75 mg/0.2 mg, 60-count bottle, Rx only, Manufactured by: Watson Laboratories, Inc., Corona, CA 92880, NDC 0591-0398-60, UPC 3 05910 39860 6.
Failed Tablet/Capsule Specifications: Recall due to complaints of split or broken tablets.
- 2014-10-08FDA-DrugSagent Pharmaceuticals IncClass IIZoledronic Acid Injection 5 mg per 100 mL (0.05 mg/mL), 100 mL single-use bag packaged in a foil overwrap, Rx only, Sterile, For Intravenous Infusion, Mfd. for Sagent Pharmaceuticals Schaumburg, IL ---- NDC 25021-830-82
Lack of Assurance of Sterility; leaking of premix bags
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