FDA Recall
Terminated
Historical recordClass II
AVKARE Ranitidine Tablets, USP 300 mg Rx Only NDC Manufactured for: AvKARE, Inc. Pulaski, TN 38478 a) 250 tablets NDC 42291-725-25; b) 30 tablets NDC 42291-725-30
by AVKARE Inc.
- Reason
- CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
- Published
- December 4, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
AVKARE Ranitidine Tablets, USP 150 mg Rx Only Manufactured for: AvKARE, Inc. Pulaski, TN 38478 Manufactured by: Amneal Pharmaceuticals of NY Hauppauge, NY 11788 a) 1000 tablets NDC 42291-724-10; b) 180 tablets NDC 42291-724-18; c) 60 tablets NDC 42291-724-60
by AVKARE Inc.
- Reason
- CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
- Published
- December 4, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Testosterone Cypionate 180 mg/mL/Testosterone Propionate 20mg/mL Oil Injection Solution, 10 mL per vial, New Vitalis Pharmacy
by New Vitalis Pharmacy LLC dba New Vitalis Pharmacy
- Reason
- Lack of sterility assurance.
- Published
- December 4, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
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
by AuroMedics Pharma LLC
- Reason
- Crystallization: Presence of visible particulate matter.
- Published
- December 4, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
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
by AuroMedics Pharma LLC
- Reason
- Crystallization: Presence of visible particulate matter.
- Published
- December 4, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
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
by AuroMedics Pharma LLC
- Reason
- Crystallization: Presence of visible particulate matter.
- Published
- December 4, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass III
Merical, LLC
- Product
- Leader Advanced Probiotic with 6 Probiotic Strains and 20 bi…
- Reason
- Incorrect Probiotic blend indicated in the Supplemental Facts Panel on product label.
- Published
- December 4, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Pareira (Brava) 1X Tincture, 50 mL bottle, Washington Homeopathic Products, 260 JR Hawvermale Way, Berkeley Springs, WV 25411.
by Washington Homeopathic Products, Inc.
- Reason
- CGMP Deviations: products were not manufactured under current good manufacturing practices.
- Published
- November 27, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Completed
Historical recordClass II
OCuSOFT Tetravisc Tetracaine HCl 0.5% Sterile Anesthetic Single Dose 0.6 mL, Rx only, Mfd. for OCuSOFT, Inc. PO Box 429 Richmond, TX 77406-0429 800-233-5469 Made in USA, Mfd. by: Altaire Pharmaceuticals, Inc. Aquebogue, NY 11931, NDC 54799-505-01
by Altaire Pharmaceuticals, Inc.
- Reason
- Lack of Assurance of Sterility
- Published
- November 27, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Completed
Historical recordClass II
Altaire Sterile Eye Wash, 15 mL (1/2 fl oz), Altaire Pharmaceuticals, Inc. Aquebogue, NY 11931 NDC 59390-175-13
by Altaire Pharmaceuticals, Inc.
- Reason
- Lack of Assurance of Sterility
- Published
- November 27, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Completed
Historical recordClass II
Altacaine (Tetracaine Hydrochloride) Ophthalmic Solution, USP, 0.5%, 15 mL, Rx only, Mfd. by: Altaire Pharmaceuticals Inc. Aquebogue, NY 111931, NDC 59390-181-13
by Altaire Pharmaceuticals, Inc.
- Reason
- Lack of Assurance of Sterility
- Published
- November 27, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Completed
Historical recordClass II
Perrigo Neomycin and Polymixin B Sulfates and Dexamethasone Ophthalmic Ointment, Net. Wt 3.5 gm, Sterile, Rx only, Manufactured for Perrigo Minneapolis, MN 55427, NDC 0574-4160-35
by Altaire Pharmaceuticals, Inc.
- Reason
- Lack of Assurance of Sterility
- Published
- November 27, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
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
by X-Gen Pharmaceuticals Inc.
- Reason
- Labeling: Incorrect or Missing Package Insert - the incorrect package insert version was attached.
- Published
- November 27, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
0.9% Sodium Chloride Irrigation USP 5000 mL bags, Rx Only, Baxter Healthcare Corporation Deerfield, IL 60015, NDC 0338-0047-29
by Baxter Healthcare Corporation
- Reason
- Lack of Assurance of Sterility: Product has the potential to leak.
- Published
- November 27, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Albuterol 2.5mg / Ipratropium 0.75mg/ Triamcinolone 0.5 mg 3ML Vial, For Inhalation Only, Conversio Health, San Luis Obispo, CA 93401.
by Integrated Health Concepts Inc. dba Conversio Health
- Reason
- Lack of Processing Controls
- Published
- November 27, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Albuterol 1.25mg / Ipratropium 0.5mg, 2ML Vial, For Inhalation Only, Conversio Health, San Luis Obispo, CA 93401.
by Integrated Health Concepts Inc. dba Conversio Health
- Reason
- Lack of Processing Controls
- Published
- November 27, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Albuterol 1.25mg / Ipratropium 0.5mg/ Budesonide 0.25mg, 3ML Vial, For Inhalation Only, Conversio Health, San Luis Obispo, CA 93401.
by Integrated Health Concepts Inc. dba Conversio Health
- Reason
- Lack of Processing Controls
- Published
- November 27, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Albuterol 2.5mg / Budesonide 0.5mg, 3ML Vial, For Inhalation Only, Shake Well, Conversio Health, San Luis Obispo, CA 93401.
by Integrated Health Concepts Inc. dba Conversio Health
- Reason
- Lack of Processing Controls
- Published
- November 27, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Albuterol 2.5mg / Ipratropium 0.75mg /Budesonide 0.25mg, 3ML Vial, For Inhalation Only, Shake Well, Conversio Health, San Luis Obispo, CA 93401.
by Integrated Health Concepts Inc. dba Conversio Health
- Reason
- Lack of Processing Controls
- Published
- November 27, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Albuterol 2.5mg / Ipratropium 0.75mg /Budesonide 0.5mg, 3ML Vial, For Inhalation Only, Conversio Health, San Luis Obispo, CA 93401.
by Integrated Health Concepts Inc. dba Conversio Health
- Reason
- Lack of Processing Controls
- Published
- November 27, 2019
- Distribution
- Nationwide
View recall →
Recall records are summarized from official FDA and USDA sources. Notices may be updated, reclassified, terminated, or withdrawn. Always review the linked official notice for the most current instructions.
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