FDA Recall
Terminated
Historical recordClass II
Kaiser Permanente Clotrimazole Cream USP, 1% Antifungal Cream, NET WT 1 oz (28.4 g), Manufactured by Taro Pharmaceuticals Inc. Brampton, Ontario, Canada L6T1C1 Distributed by Kaiser Foundation Hospitals Livemore, CA 94551-9756. Made in Canada. NDC 0179-8014-30
by Taro Pharmaceuticals U.S.A., Inc.
- Reason
- Failed Impurities/Degradation Specifications: An unknown degradation impurity was detected slightly above the specification limit in Clotrimazole Cream USP 1%.
- Published
- December 23, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
H-E-B - Athlete's Foot Cream Clotrimazole Cream USP, 1% Anitfungal NET WT. 0.5 oz. (14.2 g), Made with Pride & Care for H-E-B San Antonio, TX 78204 Made in Canada NDC 37808-305-01
by Taro Pharmaceuticals U.S.A., Inc.
- Reason
- Failed Impurities/Degradation Specifications: An unknown degradation impurity was detected slightly above the specification limit in Clotrimazole Cream USP 1%.
- Published
- December 23, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Equate Athlete's Foot, Clotrimazole USP 1%, Antifungal Cream, Packaged as a) NET WT. 0.5 oz (14.2g), NDC 49035-812-01, b) NET WT 2 OZ (60g), NDC 49035-812-27. Distributed by: Walmart Inc., Bentonville, AR 72716.
by Taro Pharmaceuticals U.S.A., Inc.
- Reason
- Failed Impurities/Degradation Specifications: An unknown degradation impurity was detected slightly above the specification limit in Clotrimazole Cream USP 1%.
- Published
- December 23, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
CVS Health Athlete's Foot Cream, Clotrimazole Cream USP, 1%, Antifungal, NET WT 1 OZ (28.4 g) Distributed by: CVS Pharmacy, Inc. One CVS Drive Woonsocket, RI 02895. Made in Canada NDC 59779-305-03
by Taro Pharmaceuticals U.S.A., Inc.
- Reason
- Failed Impurities/Degradation Specifications: An unknown degradation impurity was detected slightly above the specification limit in Clotrimazole Cream USP 1%.
- Published
- December 23, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Completed
Historical recordClass II
Kollidon CL-M Crospovidone Ph.Eur.Type B, USP/NF, JP, micronized, packaged in 30 kg plastic drums, Manufacturer: BASF SE, Carl-Bosch-Strabe 38, 67056 Ludwigshafen, Germany, Co-Manufactured by Siegfried PharmaChemikalien Minden GmbH, D-32423 Minden
by BASF Corporation
- Reason
- Cross contamination: the excipient was found to be contaminated with theophylline.
- Published
- December 23, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Vumerity (diroximel fumarate) delayed-release capsule, 231 mg, packaged in a) 106-count bottle, b)120-count bottle, Rx only, Manufactured for: Biogen Inc., Cambridge, MA 02142, NDC 64406-020-01
by Biogen MA Inc.
- Reason
- Failed dissolution specifications: out-of-specification test results observed during the buffer stage dissolution testing.
- Published
- December 23, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Lansoprazole Delayed-Release Orally Disintegrating Tablets, 30 mg, 100 Tablets (10 x 10 unit-dose) blister pack, Rx only, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534 NDC 68382-772-77
by Zydus Pharmaceuticals (USA) Inc
- Reason
- Failed Dissolution Specifications
- Published
- December 23, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Lansoprazole Delayed-Release Orally Disintegrating Tablets 15 mg, 100 Tablets (10x10 unit dose) blister pack, Rx only, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534 NDC 68382-771-77
by Zydus Pharmaceuticals (USA) Inc
- Reason
- Failed Dissolution Specifications
- Published
- December 23, 2020
- Distribution
- Nationwide
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 →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Hy-Vee Stores Inc
- Product
- Hy-Vee, Short Cuts, Pot Roast Mix sold by weight in approxim…
- Reason
- An ingredient used as an ingredient in the products tested positive for Listeria monocytogenes
- Published
- December 16, 2020
- Distribution
- To Hy-Vee stores in IA, IL, KS, MN, MO,…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Hy-Vee Stores Inc
- Product
- Hy-Vee, Short Cuts, Grill Ready Veggie Mix sold by weight in…
- Reason
- An ingredient used as an ingredient in the products tested positive for Listeria monocytogenes
- Published
- December 16, 2020
- Distribution
- To Hy-Vee stores in IA, IL, KS, MN, MO,…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass III
JMH International, LLC
- Product
- Chef Myron's Premium Shoyu Sauce, 1 GAL (3.78 L), Item # 400…
- Reason
- Product utilized a gluten-free claim but has as an ingredient a fermented soy sauce that is produced from wheat which was not processed to remove the gluten prior to fermentation.
- 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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