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.
- 2016-10-05FDA-DrugPharmatech LLCClass IISenna Syrup (sennosides) 8.8 mg, 8 fl. oz. (237 mL) bottle, Distributed by: Major Pharmaceuticals, 31778 Enterprise Drive, Livonia, MI 48150, NDC 0904-6289-09.
CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product contamination with the bacteria B. cepacia.
- 2016-10-05FDA-DrugPharmatech LLCClass IISenexon Liquid (sennosides) 8.8 mg, 8 fl oz. (237 mL) bottle, Distributed by: Rugby Laboratories, 31778 Enterprise Drive, Livonia, MI 48150, NDC 0536-1000-59.
CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product contamination with the bacteria B. cepacia.
- 2016-10-05FDA-DrugPharmatech LLCClass IIDiocto Syrup (docusate sodium), 60 mg/15 mL, One Pint (473 mL) bottle, Dist. by: Rugby Laboratories, 31778 Enterprise Drive, Livonia, MI 48150, NDC 0536-1001-85.
CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product contamination with the bacteria B. cepacia.
- 2016-10-05FDA-DrugPharmatech LLCClass IIAller-Chlor (chlorpheniramine maleate) Syrup, USP, 2 mg in each 5 mL, 4 fl oz (120 mL) bottle, Distributed by: Rugby Laboratories, 31778 Enterprise Drive, Livonia, MI 48150, NDC 0536-1025-47.
CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product contamination with the bacteria B. cepacia.
- 2016-10-05FDA-DrugPharmatech LLCClass IINinjacof-A (acetaminophen, chlophedianol HCl, pyrilamine maleate) Liquid, 160 mg/12.5 mg/12.5 mg in each 5 mL, 16 fl oz (473 mL) bottle, Manufactured for: Centurion Labs, LLC, Birmingham, AL 35243, NDC 23359-033-16.
CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product contamination with the bacteria B. cepacia.
- 2016-10-05FDA-DrugPharmatech LLCClass IINinjacof (chlophedianol HCl and pyrilamine maleate) Liquid, 12.5 mg/12.5 mg in each 5 mL, 16 fl oz (473 mL) bottle, Manufactured for: Centurion Labs, LLC, Birmingham, AL 35243, NDC 23359-032-16.
CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product contamination with the bacteria B. cepacia.
- 2016-10-05FDA-DrugPharmatech LLCClass IISennazon (sennosides) Syrup, 8.8 mg, 8 fl. oz. (237 mL) bottle, Mfd. for: Bayshore Pharmaceuticals, Tampla, FL 33619, NDC 76518-100-08.
CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product contamination with the bacteria B. cepacia.
- 2016-10-05FDA-DrugUnichem Pharmaceuticals Usa IncClass IIILamotrigine Tablets, USP, 150 mg, 500-count Tablets per bottle, Rx only, Manufactured by: Unichem Laboratories LTD., Pilerne Ind. Estate, Pilerne, Bardez, Goa 403 511 India; Marketed by: Unichem Pharmaceuticals (USA), Inc ., Rochelle Park, NJ 07662; NDC 29300-113-05.
Tablets/Capsules Imprinted With Wrong ID: incorrect imprint debossed on the tablets.
- 2016-09-28FDA-DrugGenzyme Corporation / Genzyme BiosurgeryClass IIIMozobil (plerixafor injection) 24 mg/1.2 mL (20 mg/mL) per vial, Rx Only, For Subcutaneous Injection only, Manufactured by: Genzyme Corporation, 500 Kendall Street, Cambridge, MA 02142 A Sanofi Company Country of Origin : United Kingdom, NDC 0024-5862-01
Labeling: Incorrect or Missing Lot and/or Exp. Date
- 2016-09-28FDA-DrugReckitt Benckiser LLCClass IIIMucinex Sinus-Max Day Night, 60 caplets, Dist. by Reckitt Benckiser, Parsippany, NJ 07054-0224 UPC 363824951737 NDC 63824-207-60
Labeling: Label Error on Declared Strength; label on outer carton incorrectly states Diphenhydramine 25 mg instead of 12.5 mg. Also, quantity is incorrectly stated as 30 daytime and 30 nighttime instead of 36 daytime and 24 nighttime.
- 2016-09-28FDA-DrugLupin LimitedClass IIIEscitalopram Tablets USP 20 mg, 100-count bottles, Rx Only, Manufactured for: Lupin Pharmaceuticals, Baltimore, MD, 21202, Manufactured by: Lupin Limited, Goa 403 722, India, NDC 68180-136-01
Labeling: Incorrect or Missing Lot and/or Expiration Date
- 2016-09-28FDA-DrugWest-Ward Pharmaceuticals Corp.Class IIIAmoxicillin For Oral Suspension, USP - Dye Free, 400 mg/5 mL, 100 mL (when reconstituted), Rx only, Manufactured by: Hikma Pharmaceuticals, PO Box 182400, Amman 11118 - Jordan, Distributed by: West-Ward Pharmaceutical Corp. Eatontown, NJ 07724, NDC 00143-9887-01,
Labeling: Label Error on Declared Strength- bottles missing colored coded panel where strength of the product is displayed.
- 2016-09-28FDA-DrugSandoz IncClass IIPhenylephrine HCI Injection, USP, 10mg/mL, packaged in a) 5 mL Vial, 50 mg/5 mL (NDC 66758-016-03), 25 x 5 mL Vials per carton (NDC 66758-016-04) and b) 10 mL Vials, 100 mg/10 mL (NDC 66758-017-01), Rx only, Manufactured for: Sandoz Inc., Princeton, NJ 08540.
Lack of Assurance of Sterility: a recent FDA inspection at the manufacturing firm raised concerns that product sterility may be compromised.
- 2016-09-28FDA-DrugSandoz IncClass IIEphedrine Sulfate Injection, USP, 50 mg/mL, 1 mL Fill in a 2mL Vial (NDC 66758-008-01), packaged in 25 x 2 mL Vials per carton (NDC 66758-008-02), Rx only, Manufactured for: Sandoz Inc., Princeton, NJ 08540.
Lack of Assurance of Sterility: a recent FDA inspection at the manufacturing firm raised concerns that product sterility may be compromised.
- 2016-09-28FDA-DrugW & C dba The ApothecaryClass IIProstaglandin 200 mcg/ 0.1 mL -- 25 mL GLASS VIAL, Rx only, THE APOTHECARY, A COMPOUNDING PHARMACY, 165 19th St S #102, Sartell, MN 56377
Lack of assurance of sterility: This recall includes of all unexpired lots medications containing Calcium Gluconate, Papaverine, Phentolamine, and /or Prostaglandin) due to unsubstantiated validation of beyond use dating.
- 2016-09-28FDA-DrugW & C dba The ApothecaryClass IIPapaverine 75 mg / Phentolamine 2.5 mg / Prostaglandin 25 mcg -- 4.2 mL GLASS VIAL, Rx only, THE APOTHECARY, A COMPOUNDING PHARMACY, 165 19th St S #102, Sartell, MN 56377
Lack of assurance of sterility: This recall includes of all unexpired lots medications containing Calcium Gluconate, Papaverine, Phentolamine, and /or Prostaglandin) due to unsubstantiated validation of beyond use dating.
- 2016-09-28FDA-DrugW & C dba The ApothecaryClass IIPapaverine 30 mg / Phentolamine 1 mg / mL -- 5 mL GLASS VIAL, Rx only, THE APOTHECARY, A COMPOUNDING PHARMACY, 165 19th St S #102, Sartell, MN 56377
Lack of assurance of sterility: This recall includes of all unexpired lots medications containing Calcium Gluconate, Papaverine, Phentolamine, and /or Prostaglandin) due to unsubstantiated validation of beyond use dating.
- 2016-09-28FDA-DrugW & C dba The ApothecaryClass IICalcium Gluconate 2.5% -- 20 mL PLASTIC SYRINGE, Rx only, THE APOTHECARY, A COMPOUNDING PHARMACY, 165 19th St S #102, Sartell, MN 56377
Lack of assurance of sterility: This recall includes of all unexpired lots medications containing Calcium Gluconate, Papaverine, Phentolamine, and /or Prostaglandin) due to unsubstantiated validation of beyond use dating.
- 2016-09-28FDA-DrugW & C dba The ApothecaryClass IICalcium Gluconate 1% -- 1000 mL VIAFLEX IV BAG, Rx only, THE APOTHECARY, A COMPOUNDING PHARMACY, 165 19th St S #102, Sartell, MN 56377
Lack of assurance of sterility: This recall includes of all unexpired lots medications containing Calcium Gluconate, Papaverine, Phentolamine, and /or Prostaglandin) due to unsubstantiated validation of beyond use dating.
- 2016-09-28FDA-DrugSun Pharmaceutical Industries, Inc.Class IIICarvediol Tablets, USP, 25 mg, 100-count bottle (NDC 57664-247-88), 500-count bottle (NDC 57664-247-13), 1000-count bottle (NDC 57664-247-18), Rx Only Manufactured by: ALKALOIDA Chemical Company Zrt 440 Tisavasvari Kabay Janos u. 29 Hungary, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512
Failed Impurities/Degradation Specifications
- 2016-09-28FDA-DrugSun Pharmaceutical Industries, Inc.Class IIICarvediol Tablets, USP, 12.5 mg, 500-count bottle (NDC 57664-245-13), 1000-count bottle (NDC 57664-245-18), Rx Only Manufactured by: ALKALOIDA Chemical Company Zrt 440 Tisavasvari Kabay Janos u. 29 Hungary, Distributed by Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512
Failed Impurities/Degradation Specifications
- 2016-09-28FDA-DrugSun Pharmaceutical Industries, Inc.Class IIICarvediol Tablets, USP, 6.25 mg, 100-count bottle (NDC 57664-244-18), 500-count bottle (NDC 57664-244-13), 1000-count bottle (NDC 57664-244-18), Rx Only, Manufactured by: ALKALOIDA Chemical Company Zrt 440 Tisavasvari Kabay Janos u. 29 Hungary, Distributed by Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512
Failed Impurities/Degradation Specifications
- 2016-09-28FDA-DrugSun Pharmaceutical Industries, Inc.Class IIICarvediol Tablets , USP, 3.125 mg, 100-count bottle (NDC 57664-242-88). 500-count bottle (NDC 57664-242-13), 1000-count bottle (NDC 57664-242-18), Rx Only Manufactured by: ALKALOIDA Chemical Company Zrt 440 Tisavasvari Kabay Janos u. 29 Hungary, Distributed by Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512
Failed Impurities/Degradation Specifications
- 2016-09-28FDA-DrugLupin Pharmaceuticals Inc.Class IIILisinopril Tablets USP, 40 mg, 1000-count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, MD 21202, United States; Manufactured by: Lupin Limited, Pithampur (M.P.) 454 775, INDIA, NDC 68180-517-03.
CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.
- 2016-09-28FDA-DrugLupin Pharmaceuticals Inc.Class IIILisinopril Tablets USP, 30 mg, packaged in a) 500-count bottles (NDC 68180-516-02) and b) 100-count bottles (NDC 68180-516-01); Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, MD 21202, United States; Manufactured by: Lupin Limited, Pithampur (M.P.) 454 775, INDIA.
CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.
- 2016-09-21FDA-DrugAmerisource Health ServicesClass IIIbuPROPion Hydrochloride Extended-Release Tablets, USP (XL), 300mg, 500-count bottle, Rx only, Manufactured by: Cadila Healthcare Ltd., Ahmedabad, India For BluePoint Laboratories, NDC 68001-264-03
Failed dissolution specifications - the out of specification result for dissolution was identified during 3 month stability testing.
- 2016-09-21FDA-DrugHospira Inc.Class IIDOBUTamine Injection, USP 250 mg/20 mL, 20 mL Vial, For IV Use Only, Must be Diluted Prior to Use, (12.5 mg per mL), Rx Only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-2025-20
Discoloration: Firm received complaints of product discoloration and particulates.
- 2016-09-21FDA-DrugAurobindo Pharma USA IncClass IIPantoprazole Sodium Delayed-Release Tablets USP, 40 mg Rx Only, 90 tablets per bottle, Manufactured for Aurobindo Pharma USA, Inc 2400 Route 130 North Dayton, NJ 08810, Manufactured by: Aurobindo Pharma Limited Unit-VII (SE2), Mahaboob Nagar (Dt) - 509302, India , NDC 65862-0560-90
Presence of Foreign Tablets/Capsules: Firm received a market complaint stating the presence of one foreign tablet (Montelukast Sodium Chewable Tab 4mg) in the product bottle of Pantoprazole.
- 2016-09-14FDA-DrugAllergy Laboratories, Inc.Class IIEphedrine Sulfate Injection, USP, 50 mg/mL, Single Dose Vial, packaged in a) 1 mL fill in a 2 mL Vial (NDC: 69053-008-01); and b) 25 x 2 mL Vials (NDC 69053-008-02), Rx only, Manufactured for: Andersen Pharmaceutical, White Plains, NY 10605.
Lack of Assurance of Sterility: An FDA inspection at the facility raised concerns that product sterility was potentially impacted.
- 2016-09-14FDA-DrugTeva North AmericaClass IIOndansetron Injection USP 40 mg/20 mL (2 mg/mL), Rx Only, Manufactured in Hungary for TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454 NDC # 0703-7226-01 (20 mL- Multi-dose Vial), NDC # 0703-72263-03 (10 Multi-dose Vials per carton)
CGMP Deviations
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