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.
- 2016-04-06FDA-DrugWalter's PharmacyClass IISilver Nitrate 1% Ophth Solution, 5mL bottle, Rx only, Walter's Pharmacy 401 N 17th St., Allentown, PA 610-435-4706, NDC 99999-9991-92
Lack of Assurance of Sterility
- 2016-04-06FDA-DrugWalter's PharmacyClass IIRose Bengal 1% Ophth Solution, 5mL bottle, Rx only, Walter's Pharmacy 401 N 17th St., Allentown, PA 610-435-4706
Lack of Assurance of Sterility
- 2016-04-06FDA-DrugWalter's PharmacyClass IILidocaine Nebulizer 2% Solution, packaged in 50mL, 100mL, 120mL, and 150mL bottles, Rx only, Walter's Pharmacy, 401 N 17th St, Allentown, PA 610-435-4706, NDC 99999-9000-99
Lack of Assurance of Sterility
- 2016-04-06FDA-DrugWalter's PharmacyClass IIEdetate Disodium 3% Ophth Solution, 10mL 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 IICefazolin 50 mg/mL Ophth Solution, 10mL bottle, Rx only, Walter's Pharmacy, 401 N 17th St, Allentown, PA 610-435-4706, NDC 99999-9999-69 / 89999-9001-04
Lack of Assurance of Sterility
- 2016-04-06FDA-DrugSafecor Health, LLCClass IIPhenobarbital/Hyoscyamine/ Atropine/Scopolamine 16.2/0.1037/0.0194/0.0065 mg DONNATAL ELIXIR, 5 ml Cup grape, Alcohol 23.8%, Rx Only, MFG: Concordia, PKG BY: SAFECOR HEALTH, WOBURN, MA, C5921242304.
Labeling: Label Error on Declared Strength: Label incorrectly identifies product dose as 5ml instead of 10 ml.
- 2016-04-06FDA-DrugDr. Reddy's Laboratories, Inc.Class IIZoledronic Acid Injection, 5 mg/100 mL (0.05 mg/mL), 100 mL Single Use Bottle, Rx Only, Mfd. By: Gland Pharma Limited D.P. Pally - 500 043 INDIA NDC 55111-688-52
Lack of Assurance of Sterility; defective seals where the metal silver ring was not attached tightly to the vial
- 2016-04-06FDA-DrugPraxair Inc.Class IIIUN1002 Air, Compressed, Medical Air, USP, Distributed by Praxair Distribution, Inc. Roseville, MN 55113,
CGMP Deviations: Confirmed customer compliant of odor when turning on a cylinder of medical air.
- 2016-04-06FDA-DrugPraxair Inc.Class IIIUN1002 Air, Compressed, Breathing Grade, USP, Distributed by Praxair Distribution, Inc. Roseville, MN 55113, NDC 59579-006.
CGMP Deviations: Confirmed customer compliant of odor when turning on a cylinder of medical air.
- 2016-03-30FDA-DrugAstraZeneca Pharmaceuticals LPClass IITudorza Pressair (aclindinium bromide inhalation powder), 400 mcg per actuation, 60 Metered Doses per Inhaler, Rx Only. Manufactured for: AstraZeneca Pharmaceuticals LP, Wilmington, DE 19850. Manufactured by: Forest Laboratories, Ireland Limited, Dublin 17 Ireland. Product of Spain. NDC: 0310-0800-60.
Defective Delivery System: Some units have actuation counters set to a number other than 60.
- 2016-03-30FDA-DrugSagent Pharmaceuticals IncClass IIFluconazole Injection, USP (in 0.9% Sodium Chloride), 200 mg per 100 ml, Single-Dose Container Bag, Rx only, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195, NDC 25021-0113-82
Cross contamination with other products: metronidazole
- 2016-03-30FDA-DrugAGA Gas IncClass IIOxygen, USP, 99.0%, Bulk Cryogenic Liquid, Rx, Airgas Merchant Gases, LLC, Independence, OH --- NDC 33237-001-01
cGMP Deviations; trailer may not have met GMP requirements prior to filling
- 2016-03-23FDA-DrugPharmedium Services, LLCClass IIINORepinephrine Bitartrate, 8 mg (32 mcg/mL) added to 250 mL 0.9% Sodium Chloride Injection USP, in 250 mL Viaflex Bag Black, Rx only, PharMEDium Services, LLC, Sugar Land, TX NDC 61553-127-61
Subpotent Drug; confirmed results by FDA analysis after customer complaints of discoloration
- 2016-03-23FDA-DrugPharmedium Services, LLCClass IIINORepinephrine Bitartrate, 4 mg (16 mcg/mL) added to 250 mL 0.9% Sodium Chloride Injection USP, in 250 mL Viaflex Bag, Rx only, PharMEDium Services, LLC, Sugar Land, TX NDC 61553-134-61
Subpotent Drug; confirmed results by FDA analysis after customer complaints of discoloration
- 2016-03-23FDA-DrugMedical Park Homecare, IncClass IIIOxygen, Compressed USP (Gaseous, Medical Oxygen, Aluminum Cylinders), Packaged in a) M6-Tanks, b) D-Tanks, and c) E-Tanks, Rx Only. Medical Park Homecare, 139 SE Katherine Ave., Bartlesville, OK 74006.
CGMP Deviations: Cylinders filled using out of date gauges.
- 2016-03-23FDA-DrugVirtus Pharmaceuticals, LlcClass IIIVirt-Nate Prenatal/Postnatal, Prescription Folate-Containing Dietary Supplement, Rx, 100 count bottles, Manufactured For: Virtus Pharmaceuticals, Tampa, FL
Tablets/Capsules Imprinted with Wrong ID; product debossed with an incorrect punch. Bottles could contain tablets debossed with V259 (debossing for PreTab) instead of the correct punch, V264 (debossing for Virt-Nate).
- 2016-03-23FDA-DrugTeva Pharmaceuticals USAClass IIParicalcitol Capsules, 1 mcg, 30 tablets per Bottle, Rx Only, Manufactured By: Pharmaceutics International, Inc., Hunt Valley, MD 21031, Manufactured For: Teva Pharmaceuticals USA, Sellersville, PA 18960, NDC 0093-7656-56.
Failed Impurities/Degradation Specifications: Out of specification test results for impurities during stability testing.
- 2016-03-23FDA-DrugTeva Pharmaceuticals USAClass IIINABUMETONE Tablets USP, 750 mg, 100 count bottle,Teva Pharmaceutical Industries Ltd., Jerusalem, 91010, ISRAEL
Labeling: Not Elsewhere Classified: Lack of leaflets and approved labels on bottles.
- 2016-03-16FDA-DrugTf SupplementsClass IRhino 7 Platinum 3000, 1 count Blister Pack, Distributed by Rhino 7, Made in USA, UPC 700729253748
Marketed without an Approved NDA/ANDA: Products contain undeclared desmethyl carbondenafil and dapoxetine.
- 2016-03-16FDA-DrugTf SupplementsClass IRHINO 7 3000, 6 count Bottle, Distributed by Rhino 7, Made in USA
Marketed without an Approved NDA/ANDA: Products contain undeclared desmethyl carbondenafil and dapoxetine.
- 2016-03-16FDA-DrugGolden State Medical Supply Inc.Class IIIAtorvastatin Calcium 80 mg, 10 tablets per blister,100-count package, Rx Only Manufactured by Apotex Inc. Toronto, Ontario, Canada, Packaged by GSMS Inc., Camarillo, CA 93010, NDC # 60429-326-77
Failed Impurities/Degradation Specifications
- 2016-03-16FDA-DrugGolden State Medical Supply Inc.Class IIIAtorvastatin Calcium 40 mg, 10 tablets per blister,100-count package, Rx Only Manufactured by Apotex Inc. Toronto, Ontario, Canada, Packaged by GSMS Inc., Camarillo, CA 93010, NDC # 60429-325-77
Failed Impurities/Degradation Specifications
- 2016-03-16FDA-DrugGolden State Medical Supply Inc.Class IIIAtorvastatin Calcium 20 mg, 10 tablets per blister,100-count package, Rx Only Manufactured by Apotex Inc. Toronto, Ontario, Canada, Packaged by GSMS Inc., Camarillo, CA 93010, NDC # 60429-324-77
Failed Impurities/Degradation Specifications
- 2016-03-16FDA-DrugGolden State Medical Supply Inc.Class IIIAtorvastatin Calcium 10 mg, 10 tablets per blister,100-count package, Rx Only Manufactured by Apotex Inc. Toronto, Ontario, Canada, Packaged by GSMS Inc., Camarillo, CA 93010, NDC # 60429-323-77
Failed Impurities/Degradation Specifications
- 2016-03-16FDA-DrugEcolab IncClass IIIScrub-Stat 4 (chlorhexidine gluconate) Foam Forming Solution, 4%, packaged in a) 800 mL Plastic (HDPE) Bottles (NDC 47593-265-36), b) 1250 mL Plastic (HDPE) Bottles (NDC 47593-468-59), OTC, Ecolab, St Paul, MN 55102
Subpotent drug
- 2016-03-16FDA-DrugHartley Medical Center Pharmacy, IncorporatedClass IISufentanil Cit 50 mcg/ml/Clonidine HCL 1 mcg/ml/Bupivacaine HCL 5 mg/ml, vol. 20 ml syringe, Rx only, Hartley Med Ctr Pharmacy, Long Beach, CA
Lack of Assurance of Sterility
- 2016-03-16FDA-DrugHartley Medical Center Pharmacy, IncorporatedClass IIHydromorphone HCL 0.5 mg/ml, vol. 20 ml syringe, Rx only, Hartley Med Ctr Pharmacy, Long Beach, CA
Lack of Assurance of Sterility
- 2016-03-16FDA-DrugHartley Medical Center Pharmacy, IncorporatedClass IIMorphine Sulfate 0.5 mg/ml, vol. 20 ml syringe, Rx only, Hartley Med Ctr Pharmacy, Long Beach, CA
Lack of Assurance of Sterility
- 2016-03-16FDA-DrugHartley Medical Center Pharmacy, IncorporatedClass IIMorphine Sulfate 20 mg/ml, vol. 42 ml syringe, Rx only, Hartley Med Ctr Pharmacy, Long Beach, CA
Lack of Assurance of Sterility
- 2016-03-16FDA-DrugHartley Medical Center Pharmacy, IncorporatedClass IISufentanil Cit 200 mcg/ml/Clonidine HCL 1600 mcg/ml, vol. 42 ml syringe, Rx only, Hartley Med Ctr Pharmacy, Long Beach, CA
Lack of Assurance of Sterility
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