FDA Recall
TerminatedTerminated: January 30, 2020Historical recordClass II
Methyl-Cobalamin injectable, 1 mg/mL, packaged in a) 5 mL and b) 30 mL Multiple Dose vials, Rx only, Central Drugs Compounding Pharmacy, 520 W. La Habra Blvd, La Habra, CA 90631
by Auro Pharmacies, Inc.
- Reason
- Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of products intended to be sterile.
- Published
- September 5, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: January 30, 2020Historical recordClass II
Glutathione injectable, 200 mg/mL, 30 mL Multiple Dose vial, Rx only, Central Drugs Compounding Pharmacy, 520 W. La Habra Blvd, La Habra, CA 90631
by Auro Pharmacies, Inc.
- Reason
- Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of products intended to be sterile.
- Published
- September 5, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: January 30, 2020Historical recordClass II
Dexpanthenol injectable, 250 mg/mL, 10 mL Single Dose vial, Rx only, Central Drugs Compounding Pharmacy, 520 W. La Habra Blvd, La Habra, CA 90631
by Auro Pharmacies, Inc.
- Reason
- Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of products intended to be sterile.
- Published
- September 5, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: January 30, 2020Historical recordClass II
Calcium Gluconate injectable, 10%, 50 ml Single Dose vial, Rx only, Central Drugs Compounding Pharmacy, 520 W. La Habra Blvd, La Habra, CA 90631
by Auro Pharmacies, Inc.
- Reason
- Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of products intended to be sterile.
- Published
- September 5, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: January 30, 2020Historical recordClass II
CoEnzyme-Q10 injectable, 20 mg/mL, 10 mL Multiple Dose vial, Rx only, Central Drugs Compounding Pharmacy, 520 W. La Habra Blvd, La Habra, CA 90631
by Auro Pharmacies, Inc.
- Reason
- Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of products intended to be sterile.
- Published
- September 5, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: January 18, 2022Historical recordClass II
Ipamorelin 9 mg vial Lyophilized 1109 East Hallandale Beach Blvd. Hallandale Beach, FL 33009
by Pharmcore Inc.
- Reason
- Lack of assurance of sterility.
- Published
- September 5, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: January 18, 2022Historical recordClass II
Methylcobalamin 10 mg vial Lyophilized 1109 East Hallandale Beach Blvd. Hallandale Beach, FL 33009
by Pharmcore Inc.
- Reason
- Lack of assurance of sterility.
- Published
- September 5, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: January 18, 2022Historical recordClass II
Ipamorelin 3 mg Lyophilized 1 vial 1109 East Hallandale Beach Blvd. Hallandale Beach, FL 33009
by Pharmcore Inc.
- Reason
- Lack of assurance of sterility.
- Published
- September 5, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: January 18, 2022Historical recordClass II
Human Chorionic Gonadotropin 6000 IU Vial Lyophilized 1109 East Hallandale Beach Blvd. Hallandale Beach, FL 33009
by Pharmcore Inc.
- Reason
- Lack of assurance of sterility.
- Published
- September 5, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: January 18, 2022Historical recordClass II
Human Chorionic Gonadotropin 4000 IU Vial Lyophilized 1109 East Hallandale Beach Blvd. Hallandale Beach, FL 33009
by Pharmcore Inc.
- Reason
- Lack of assurance of sterility.
- Published
- September 5, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: January 18, 2022Historical recordClass II
Human Chorionic Gonadotropin 2500 IU Vial Lyophilized 1109 East Hallandale Beach Blvd. Hallandale Beach, FL 33009
by Pharmcore Inc.
- Reason
- Lack of assurance of sterility.
- Published
- September 5, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: January 18, 2022Historical recordClass II
Human Chorionic Gonadotropin 20000 IU Vial Lyophilized 1109 East Hallandale Beach Blvd. Hallandale Beach, FL 33009
by Pharmcore Inc.
- Reason
- Lack of assurance of sterility.
- Published
- September 5, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: January 18, 2022Historical recordClass II
Human Chorionic Gonadotropin 11000 IU Vial Lyophilized 1109 East Hallandale Beach Blvd. Hallandale Beach, FL 33009
by Pharmcore Inc.
- Reason
- Lack of assurance of sterility.
- Published
- September 5, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: January 18, 2022Historical recordClass II
Human Chorionic Gonadotropin 5000 IU Vial Lyophilized 1109 East Hallandale Beach Blvd. Hallandale Beach, FL 33009
by Pharmcore Inc.
- Reason
- Lack of assurance of sterility.
- Published
- September 5, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
OngoingHistorical recordClass II
Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP, 5 mg/160 mg/25 mg, 30 tablets per bottle, Rx Only, Manufactured by: Torrent Pharmaceuticals LTD., Indrad-382 721, India. NDC: 13668-329-30
by Torrent Pharma Inc.
- Reason
- CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
- Published
- September 5, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
OngoingHistorical recordClass II
Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP, 10 mg/160 mg/25 mg, 30 tablets per bottle, Rx Only, Manufactured by: Torrent Pharmaceuticals LTD., Indrad-382 721, India. NDC: 13668-328-30
by Torrent Pharma Inc.
- Reason
- CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
- Published
- September 5, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
OngoingHistorical recordClass II
Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP, 10 mg/160 mg/12.5 mg, 30 tablets per bottle, Rx Only, Manufactured by: Torrent Pharmaceuticals LTD., Indrad-382 721, India. NDC: 13668-327-30
by Torrent Pharma Inc.
- Reason
- CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
- Published
- September 5, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
OngoingHistorical recordClass II
Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP, 5 mg/160 mg/12.5 mg, 30 tablets per bottle, Rx Only, Manufactured by: Torrent Pharmaceuticals LTD., Indrad-382 721, India. NDC: 13668-326-30
by Torrent Pharma Inc.
- Reason
- CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
- Published
- September 5, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
OngoingHistorical recordClass II
Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP, 10 mg/320 mg/25 mg, 30 tablets per bottle, Rx Only, Manufactured by: Torrent Pharmaceuticals LTD., Indrad-382 721, India. NDC: 13668-325-30
by Torrent Pharma Inc.
- Reason
- CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
- Published
- September 5, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
OngoingHistorical recordClass II
Amlodipine and Valsartan Tablets, USP, 5 mg/160 mg, 30 tablets per bottle, Rx Only, Manufactured by: Torrent Pharmaceuticals LTD., Indrad-382 721, India. NDC: 13668-207-30
by Torrent Pharma Inc.
- Reason
- CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
- Published
- September 5, 2018
- 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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