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FDA Drug Recalls

18043 recall notices on file. Class I recalls involve a reasonable probability of serious adverse health consequences or death.

ProductFirmClassificationStatusReport date
Testosterone Cypionate 180 mg/mL/Testosterone Propionate 20mg/mL Oil Injection Solution, 10 mL per vial, New Vitalis Pharmacy New Vitalis Pharmacy LLC dba New Vitalis Pharmacy Class II Terminated 20191204
Amiodarone Hydrochloride Injection, USP, 900 mg per 18 mL (50 mg / mL), 18 mL Multiple Dose Vial, Rx only, Distributed by AuroMedics Pharma LLC E. Windsor, NJ. 08520, Made in India. NDC 55150-182-18 AuroMedics Pharma LLC Class III Terminated 20191204
Amiodarone Hydrochloride Injection, USP, 450 mg per 9 mL (50 mg / mL), 9 mL Single Dose Vial, Rx only, Distributed by AuroMedics Pharma LLC E. Windsor, NJ. 08520, Made in India. NDC 55150-181-09 AuroMedics Pharma LLC Class III Terminated 20191204
Amiodarone Hydrochloride Injection, USP, 150 mg per 3 mL (50 mg / mL), 3 mL Single Dose Vial, Rx only, Distributed by AuroMedics Pharma LLC E. Windsor, NJ. 08520, Made in India. NDC 55150-180-03 AuroMedics Pharma LLC Class III Terminated 20191204
Levetiracetam Injection, 500 mg/5mL, 10 single-use 5 mL vials, Rx only, Manufactured by: Agile Specialties Private Limited Pilot No. 14, Sipcot II, Hosur-635 109 Tamil Nadu, India, Manufactured for: X-Gen Pharmaceuticals, Inc. Big Flats, NY 14814, NDC 39822-4000-1 X-Gen Pharmaceuticals Inc. Class III Terminated 20191127
Valganciclovir Hydrochloride for Oral Solution, 50 mg/mL, 100 mL (3.4 fl. oz.) bottle, Rx only, Manufactured for: Actavis Laboratories FL. Inc., Fort Lauderdale, FL 33314, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054, NDC 0591-2579-20 Teva Pharmaceuticals USA, Inc. Class II Terminated 20191127
0.9% Sodium Chloride Irrigation USP 5000 mL bags, Rx Only, Baxter Healthcare Corporation Deerfield, IL 60015, NDC 0338-0047-29 Baxter Healthcare Corporation Class II Terminated 20191127
Albuterol 2.5mg / Ipratropium 0.75mg/ Triamcinolone 0.5 mg 3ML Vial, For Inhalation Only, Conversio Health, San Luis Obispo, CA 93401. Integrated Health Concepts Inc. dba Conversio Health Class II Terminated 20191127
Albuterol 1.25mg / Ipratropium 0.5mg, 2ML Vial, For Inhalation Only, Conversio Health, San Luis Obispo, CA 93401. Integrated Health Concepts Inc. dba Conversio Health Class II Terminated 20191127
Albuterol 1.25mg / Ipratropium 0.5mg/ Budesonide 0.25mg, 3ML Vial, For Inhalation Only, Conversio Health, San Luis Obispo, CA 93401. Integrated Health Concepts Inc. dba Conversio Health Class II Terminated 20191127
Albuterol 2.5mg / Budesonide 0.5mg, 3ML Vial, For Inhalation Only, Shake Well, Conversio Health, San Luis Obispo, CA 93401. Integrated Health Concepts Inc. dba Conversio Health Class II Terminated 20191127
Albuterol 2.5mg / Ipratropium 0.75mg /Budesonide 0.25mg, 3ML Vial, For Inhalation Only, Shake Well, Conversio Health, San Luis Obispo, CA 93401. Integrated Health Concepts Inc. dba Conversio Health Class II Terminated 20191127
Albuterol 2.5mg / Ipratropium 0.75mg /Budesonide 0.5mg, 3ML Vial, For Inhalation Only, Conversio Health, San Luis Obispo, CA 93401. Integrated Health Concepts Inc. dba Conversio Health Class II Terminated 20191127
Albuterol 2.5mg / Ipratropium 0.75mg, 2ML Vial, For Inhalation Only, Conversio Health, San Luis Obispo, CA 93401. Integrated Health Concepts Inc. dba Conversio Health Class II Terminated 20191127
Albuterol 3.75mg / Ipratropium 0.75mg, 3ML Vial, For Inhalation Only, Conversio Health, San Luis Obispo, CA 93401. Integrated Health Concepts Inc. dba Conversio Health Class II Terminated 20191127
Budesonide 0.4mg, 3ML Vial, For Inhalation Only, Conversio Health, San Luis Obispo, CA 93401. Integrated Health Concepts Inc. dba Conversio Health Class II Terminated 20191127
Formoterol 12mcg / Budesonide 0.5mg, 3.5ML Vial, For Inhalation Only, Shake Well, Conversio Health, San Luis Obispo, CA 93401. Integrated Health Concepts Inc. dba Conversio Health Class II Terminated 20191127
R2103, Active Ingredients: Berberis Aquifolium 3x; Borax 3; , Kreosotum 10X; Sepia 3x. Inactive ingredient: 28% dilution alcohol, packaged in a) 470 mL bottle and b) 1000 mL bottle; Manufactured for Wisconsin Pharmacal Company, By: Washington Homeopathic Products, Inc., 260 JR Hawvermale Way, Berkeley Springs, WV 25411. Washington Homeopathic Products, Inc. Class II Terminated 20191127
StellaLife VEGA Oral Gel Rinse (In equal parts of: Azadirachta Indica 1x, Calendula Officinalis 1x, Echinacea Purpurea 1x, Plantago Major 1x), packaged in 1000 mL white plastic bottle. Washington Homeopathic Products, Inc. Class II Terminated 20191127
Pareira (Brava) 1X Tincture, 50 mL bottle, Washington Homeopathic Products, 260 JR Hawvermale Way, Berkeley Springs, WV 25411. Washington Homeopathic Products, Inc. Class II Terminated 20191127
Silicea 6X Tablets, 300-count bottle, 30g, Manufactured in India exclusively for: Washington Homeopathic Products, Inc., 260 JR Hawvermale Way, Berkeley Springs, WV 25411, barcode 7 40640 64199 6. Washington Homeopathic Products, Inc. Class II Terminated 20191127
Natrum Sulphuricum 6X Tablets, 300-count bottle, 30g, Manufactured in India exclusively for: Washington Homeopathic Products, Inc., 260 JR Hawvermale Way, Berkeley Springs, WV 25411, barcode 7 40640 64193 4. Washington Homeopathic Products, Inc. Class II Terminated 20191127
Natrum Phosphoricum 6X Tablets, 300-count bottle, 30g, Manufactured in India exclusively for: Washington Homeopathic Products, Inc., 260 JR Hawvermale Way, Berkeley Springs, WV 25411, barcode 7 40640 64192 7. Washington Homeopathic Products, Inc. Class II Terminated 20191127
Natrum Muriaticum 6X Tablets, 300-count bottle, 30g, Manufactured in India exclusively for: Washington Homeopathic Products, Inc., 260 JR Hawvermale Way, Berkeley Springs, WV 25411, barcode 7 40640 64191 0. Washington Homeopathic Products, Inc. Class II Terminated 20191127
Magnesia Phosphorica 6X Tablets, 300-count bottle, 30g, Manufactured in India exclusively for: Washington Homeopathic Products, Inc., 260 JR Hawvermale Way, Berkeley Springs, WV 25411, barcode 7 40640 64197 2. Washington Homeopathic Products, Inc. Class II Terminated 20191127
Kali Sulphuricum 6X Tablets, 300-count bottle, 30g, Manufactured in India exclusively for: Washington Homeopathic Products, Inc., 260 JR Hawvermale Way, Berkeley Springs, WV 25411, barcode 7 40640 64196 5. Washington Homeopathic Products, Inc. Class II Terminated 20191127
Kali Phosphoricum 6X Tablets, 300-count bottle, 30g, Manufactured in India exclusively for: Washington Homeopathic Products, Inc., 260 JR Hawvermale Way, Berkeley Springs, WV 25411, barcode 7 40640 64195 8. Washington Homeopathic Products, Inc. Class II Terminated 20191127
Kali Muriaticum 6X Tablets, 300-count bottle, 30g, Manufactured in India exclusively for: Washington Homeopathic Products, Inc., 260 JR Hawvermale Way, Berkeley Springs, WV 25411, barcode 7 40640 64194 1. Washington Homeopathic Products, Inc. Class II Terminated 20191127
Ferrum Phosphoricum 6X Tablets, 300-count bottle, 30g, Manufactured in India exclusively for: Washington Homeopathic Products, Inc., 260 JR Hawvermale Way, Berkeley Springs, WV 25411, barcode 7 40640 64198 9. Washington Homeopathic Products, Inc. Class II Terminated 20191127
Cell Salts Combination 6X Tablets, 300-count bottle, 30g, Manufactured in India exclusively for: Washington Homeopathic Products, Inc., 260 JR Hawvermale Way, Berkeley Springs, WV 25411, barcode 7 40640 64200 9. Washington Homeopathic Products, Inc. Class II Terminated 20191127
Calcarea Sulphurica 6X Tablets, 300-count bottle, 30g, Manufactured in India exclusively for: Washington Homeopathic Products, Inc., 260 JR Hawvermale Way, Berkeley Springs, WV 25411, barcode 7 40640 64190 3. Washington Homeopathic Products, Inc. Class II Terminated 20191127
Calcarea Phosphorica 6X Tablets, 300-count bottle, 30g, Manufactured in India exclusively for: Washington Homeopathic Products, Inc., 260 JR Hawvermale Way, Berkeley Springs, WV 25411, barcode 7 40640 64189 7. Washington Homeopathic Products, Inc. Class II Terminated 20191127
Calcarea Fluorica 6X Tablets, 300-count bottle, 30g, Manufactured in India exclusively for: Washington Homeopathic Products, Inc., 260 JR Hawvermale Way, Berkeley Springs, WV 25411, barcode 7 40640 64188 0. Washington Homeopathic Products, Inc. Class II Terminated 20191127
Clear Eyes Redness Relief (Little Drug),Product Size: 0.2 FL. Oz., UPC#: 7-92554-70103-7 Altaire Pharmaceuticals, Inc. Class II Completed 20191127
Clear Eyes Redness Relief (Handy Pocket Pal), Product Size: 0.2 FL. Oz., UPC#: 6-78112-15418-7 Altaire Pharmaceuticals, Inc. Class II Completed 20191127
Clear Eyes Redness Relief, Product Size: 15 mL, UPC#: 6-78112-25415-6 Altaire Pharmaceuticals, Inc. Class II Completed 20191127
Grandall Oftal-Mycin Ophthalmic Ointment, Product Size: 3.5 g Altaire Pharmaceuticals, Inc. Class II Completed 20191127
Grandall Colirio Oftal-Mycin Redness Relief Eye Drops, Product Size: 15mL Altaire Pharmaceuticals, Inc. Class II Completed 20191127
FreshKote Lubricant Eye Drops, Product Size: 15 mL, NDC 15821-101-15 Altaire Pharmaceuticals, Inc. Class II Completed 20191127
OCuSOFT retaine NaCl Ophthalmic Ointment, Product Size: 3.5g, SKU #: 777-3-77 Altaire Pharmaceuticals, Inc. Class II Completed 20191127
OCuSOFT retaine NaCl Ophthalmic Ointment, Product Size: 3.5g, SKU #: 777-3-76 Altaire Pharmaceuticals, Inc. Class II Completed 20191127
Nano Tears XP Clear Emollient Lubricant Gel Drops twin pack, Product Size: 2 x 10 mL, Mfd. by: Altaire Pharmaceuticals, Inc., Aquebogue, NY 11931, NDC 59390-143-51 Altaire Pharmaceuticals, Inc. Class II Completed 20191127
Nano Tears MXP Forte Clear Emollient Lubricant Gel Drops, Twin Pack 2 x 10 mL, Mfd. by: Altaire Pharmaceuticals, Inc., Aquebogue, NY 11931, NDC 59390-144-51 Altaire Pharmaceuticals, Inc. Class II Completed 20191127
Altaire Ciprofloxacin HCl Ophthalmic Solution, 0.3%, 5 mL, NDC 59390-217-05 Altaire Pharmaceuticals, Inc. Class II Completed 20191127
CVS Health Multi-Action Relief Drops, Item#: 694954, 15 mL, Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895 Altaire Pharmaceuticals, Inc. Class II Completed 20191127
CVS Health Preservative Free Lubricant Gel Drops Dry Eye Relief, Item#: 634634, Product Size: 0.6 mL x 30, Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895 Altaire Pharmaceuticals, Inc. Class II Completed 20191127
Equate Support Advanced Lubricant Gel Drops Multi Dose Preservative Free, 7.5 mL, NDC 49035-882-52 Altaire Pharmaceuticals, Inc. Class II Completed 20191127
Puralube Ophthalmic Ointment, 3.5 gram, Mfd. for Perrigo, Minneapolis, MN 55427, NDC 0574-4025-20 Altaire Pharmaceuticals, Inc. Class II Completed 20191127
Puralube Petrolatum Ophthalmic Ointment, Net Wt 3.5 gram (1/8 oz), Mfd. for Perrigo, Minneapolis, MN 55427, NDC 0574-4025-35 Altaire Pharmaceuticals, Inc. Class II Completed 20191127
Nano Tears MXP Forte Clear Emollient Lubricant Gel Drops Twin Pack, Product Size: 2 x 10 mL, NDC 59390-144-51 Altaire Pharmaceuticals, Inc. Class II Completed 20191127