FDA Recall
Ongoing
Historical recordClass II
DSIP, 1000 MCG/ML, 5 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN
by Advanced Nutriceuticals, LLC
- Reason
- Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
- Published
- December 23, 2020
- Distribution
- Multiple states
View recall →
FDA Recall
Ongoing
Historical recordClass II
B12 for Injection, 2 MG/ML, 10 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN
by Advanced Nutriceuticals, LLC
- Reason
- Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
- Published
- December 23, 2020
- Distribution
- Multiple states
View recall →
FDA Recall
Ongoing
Historical recordClass II
NANDROLONE, 200 MCG/ML, 2 ML, The Guyer Institute of Molecular Medicine, Indianapolis, IN
by Advanced Nutriceuticals, LLC
- Reason
- Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
- Published
- December 23, 2020
- Distribution
- Multiple states
View recall →
FDA Recall
Ongoing
Historical recordClass II
GHRP, 2000 MCG/ML, 5 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN
by Advanced Nutriceuticals, LLC
- Reason
- Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
- Published
- December 23, 2020
- Distribution
- Multiple states
View recall →
FDA Recall
Ongoing
Historical recordClass II
IPAMORELIN, 2000 MCG/ML, 5 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN
by Advanced Nutriceuticals, LLC
- Reason
- Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
- Published
- December 23, 2020
- Distribution
- Multiple states
View recall →
FDA Recall
Ongoing
Historical recordClass II
THYMOSIN ALPHA, 2000 MCG/ML, 5 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN
by Advanced Nutriceuticals, LLC
- Reason
- Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
- Published
- December 23, 2020
- Distribution
- Multiple states
View recall →
FDA Recall
Ongoing
Historical recordClass II
BPC-157, 2000 MCG/ML, 5 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN
by Advanced Nutriceuticals, LLC
- Reason
- Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
- Published
- December 23, 2020
- Distribution
- Multiple states
View recall →
FDA Recall
Ongoing
Historical recordClass II
AOD-9604, 1200 MCG/ML, 5 ML vial The Guyer Institute of Molecular Medicine, Indianapolis, IN
by Advanced Nutriceuticals, LLC
- Reason
- Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
- Published
- December 23, 2020
- Distribution
- Multiple states
View recall →
FDA Recall
Ongoing
Historical recordClass II
PT-141, 10 MG/ML, 2 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN
by Advanced Nutriceuticals, LLC
- Reason
- Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
- Published
- December 23, 2020
- Distribution
- Multiple states
View recall →
FDA Recall
Ongoing
Historical recordClass II
FGL, 10 MG/ML, 3 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN
by Advanced Nutriceuticals, LLC
- Reason
- Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
- Published
- December 23, 2020
- Distribution
- Multiple states
View recall →
FDA Recall
Ongoing
Historical recordClass II
CJC-1295, 2000 MCG/ML, 5 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN
by Advanced Nutriceuticals, LLC
- Reason
- Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
- Published
- December 23, 2020
- Distribution
- Multiple states
View recall →
FDA Recall
🇺🇸 United States
Ongoing
Historical recordClass II
Fusion Health and Vitality LLC
- Product
- PHARMORIGINS CORE with Natural Orange Flavor NATURAL ENERGY…
- Reason
- The firm is recalling their products due the unapproved use of a food additive and unapproved marketing statements
- Published
- December 23, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Scandonest 3% Plain (Mepivacaine Hydrochloride 3% without Vasoconstrictor), packaged in cartons of 50 cartridges (1.7 mL each), Rx only, Manufactured for SEPTODONT, Inc., Louisville, CO 80027, by Novocol Pharmaceutical of Canada, Inc., Cambridge, ON N1R 6X3, Canada, NDC 0362-1098-90
by Novocol Pharmaceutical of Canada, Inc.
- Reason
- Labeling: Label mix-up
- Published
- December 16, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Docetaxel Injection USP 160 mg/8mL (20 mg/mL), For Intravenous Infusion Only, Rx Only, 8 mL Single Use Vial, Cytotoxic Agent, Manufactured by: Shilpa Medicare Limited, India, Distributed by: Armas Pharmaceuticals, Inc., Manalapan, NJ 07726, NDC 72485-216-08.
by Shilpa Medicare Limited
- Reason
- CGMP Deviations
- Published
- December 16, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Imatinib Mesylate Tablets 400 mg, Rx Only, 30-count Bottle, Manufactured by: Shilpa Medicare Limited, India, Distributed by: Armas Pharmaceuticals Inc., Manalapan, NJ 07726, NDC 72485-203-30.
by Shilpa Medicare Limited
- Reason
- CGMP Deviations
- Published
- December 16, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Imatinib Mesylate Tablets 100 mg, Rx Only, 90-count Bottle, Manufactured by: Shilpa Medicare Limited, India, Distributed by: Armas Pharmaceuticals Inc., Manalapan, NJ 07726, NDC 72485-202-90.
by Shilpa Medicare Limited
- Reason
- CGMP Deviations
- Published
- December 16, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Azacitidine for Injection 100 mg/vial, For Subcutaneous and Intravenous Use Only, Rx Only, One Single Dose Vial, Cytotoxic Agent, Manufactured by: Shilpa Medicare Limited, India, Distributed by: Armas Pharmaceuticals, Inc., Manalapan, NJ 07726, NDC 72606-558-01.
by Shilpa Medicare Limited
- Reason
- CGMP Deviations
- Published
- December 16, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Azacitidine for Injection 100 mg/vial, For Subcutaneous and Intravenous Use Only, Rx Only, One Single Dose Vial, Cytotoxic Agent, Manufactured by: Shilpa Medicare Limited, Jadcherla, 509301, India, Distributed by: Armas Pharmaceuticals, Inc. Manalapan, NJ 07726 NDC 72485-201-01.
by Shilpa Medicare Limited
- Reason
- CGMP Deviations
- Published
- December 16, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Busulfan Injection 60 mg/10 mL (6 mg/mL), For Intravenous Infusion Only, Must be diluted before use, Single Dose Vial, Sterile, Cytotoxic Agent, Rx Only, 10 mL vial, Manufactured by: Shilpa Medicare Limited, India, Distributed by: Armas Pharmaceuticals, Inc., Manalapan, NJ 07726, Vial NDC 72485-210-01, Carton NDC 72485-210-08.
by Shilpa Medicare Limited
- Reason
- CGMP Deviations
- Published
- December 16, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
Dexmedetomidine HCl in 0.9% Sodium Chloride Injection, 200 mcg / 50 mL (4 mcg / mL), 50 mL Single Dose Bottle, Rx only, Fresenius Kabi, Lake Zurich, IL 60047, NDC 63323-671-05
by Fresenius Kabi USA, LLC
- Reason
- Cross Contamination with other products: trace amounts of lidocaine
- Published
- December 16, 2020
- 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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