Drug 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.
- Recall initiated
- October 11, 2019
- Reported by FDA
- November 27, 2019
- Distribution
- U.S.A. Nationwide
View recall →
Drug Recall
Terminated
Historical recordClass II
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
by Teva Pharmaceuticals USA, Inc.
- Reason
- Presence of foreign substance: Brown/black particles found during stability testing.
- Recall initiated
- November 4, 2019
- Reported by FDA
- November 27, 2019
- Distribution
- Product was distributed to wholesalers/distributors throughout the United States.
View recall →
Drug 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.
- Recall initiated
- November 19, 2019
- Reported by FDA
- November 27, 2019
- Distribution
- Nationwide within the United States
View recall →
Drug 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
- Recall initiated
- November 12, 2019
- Reported by FDA
- November 27, 2019
- Distribution
- Nationwide in the U.S.
View recall →
Drug 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
- Recall initiated
- November 12, 2019
- Reported by FDA
- November 27, 2019
- Distribution
- Nationwide in the U.S.
View recall →
Drug 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
- Recall initiated
- November 12, 2019
- Reported by FDA
- November 27, 2019
- Distribution
- Nationwide in the U.S.
View recall →
Drug 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
- Recall initiated
- November 12, 2019
- Reported by FDA
- November 27, 2019
- Distribution
- Nationwide in the U.S.
View recall →
Drug 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
- Recall initiated
- November 12, 2019
- Reported by FDA
- November 27, 2019
- Distribution
- Nationwide in the U.S.
View recall →
Drug 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
- Recall initiated
- November 12, 2019
- Reported by FDA
- November 27, 2019
- Distribution
- Nationwide in the U.S.
View recall →
Drug Recall
Terminated
Historical recordClass II
Albuterol 2.5mg / Ipratropium 0.75mg, 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
- Recall initiated
- November 12, 2019
- Reported by FDA
- November 27, 2019
- Distribution
- Nationwide in the U.S.
View recall →
Drug Recall
Terminated
Historical recordClass II
Albuterol 3.75mg / Ipratropium 0.75mg, 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
- Recall initiated
- November 12, 2019
- Reported by FDA
- November 27, 2019
- Distribution
- Nationwide in the U.S.
View recall →
Drug Recall
Terminated
Historical recordClass II
Budesonide 0.4mg, 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
- Recall initiated
- November 12, 2019
- Reported by FDA
- November 27, 2019
- Distribution
- Nationwide in the U.S.
View recall →
Drug Recall
Terminated
Historical recordClass II
Formoterol 12mcg / Budesonide 0.5mg, 3.5ML 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
- Recall initiated
- November 12, 2019
- Reported by FDA
- November 27, 2019
- Distribution
- Nationwide in the U.S.
View recall →
Drug Recall
Terminated
Historical recordClass II
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.
by Washington Homeopathic Products, Inc.
- Reason
- CGMP Deviations: products were not manufactured under current good manufacturing practices.
- Recall initiated
- November 8, 2019
- Reported by FDA
- November 27, 2019
- Distribution
- Product was distributed Nationwide throughout the United States, Canada and Saudi Arabia
View recall →
Drug Recall
Terminated
Historical recordClass II
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.
by Washington Homeopathic Products, Inc.
- Reason
- CGMP Deviations: products were not manufactured under current good manufacturing practices.
- Recall initiated
- November 8, 2019
- Reported by FDA
- November 27, 2019
- Distribution
- Product was distributed Nationwide throughout the United States, Canada and Saudi Arabia
View recall →
Drug Recall
Terminated
Historical recordClass II
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.
by Washington Homeopathic Products, Inc.
- Reason
- CGMP Deviations: products were not manufactured under current good manufacturing practices.
- Recall initiated
- November 8, 2019
- Reported by FDA
- November 27, 2019
- Distribution
- Product was distributed Nationwide throughout the United States, Canada and Saudi Arabia
View recall →
Drug Recall
Terminated
Historical recordClass II
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.
by Washington Homeopathic Products, Inc.
- Reason
- CGMP Deviations: products were not manufactured under current good manufacturing practices.
- Recall initiated
- November 8, 2019
- Reported by FDA
- November 27, 2019
- Distribution
- Product was distributed Nationwide throughout the United States, Canada and Saudi Arabia
View recall →
Drug Recall
Terminated
Historical recordClass II
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.
by Washington Homeopathic Products, Inc.
- Reason
- CGMP Deviations: products were not manufactured under current good manufacturing practices.
- Recall initiated
- November 8, 2019
- Reported by FDA
- November 27, 2019
- Distribution
- Product was distributed Nationwide throughout the United States, Canada and Saudi Arabia
View recall →
Drug Recall
Terminated
Historical recordClass II
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.
by Washington Homeopathic Products, Inc.
- Reason
- CGMP Deviations: products were not manufactured under current good manufacturing practices.
- Recall initiated
- November 8, 2019
- Reported by FDA
- November 27, 2019
- Distribution
- Product was distributed Nationwide throughout the United States, Canada and Saudi Arabia
View recall →
Drug Recall
Terminated
Historical recordClass II
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.
by Washington Homeopathic Products, Inc.
- Reason
- CGMP Deviations: products were not manufactured under current good manufacturing practices.
- Recall initiated
- November 8, 2019
- Reported by FDA
- November 27, 2019
- Distribution
- Product was distributed Nationwide throughout the United States, Canada and Saudi Arabia
View recall →
This information is republished from FDA's Recall Enterprise System through openFDA. Public Health Trace
does not verify or supplement it, is not affiliated with the FDA, and does not provide medical advice --
always follow the guidance of your pharmacist, physician, or the recalling company for any medication you take.
Read the full medical disclaimer.
