FDA Recall
Terminated
Historical recordClass II
Alprostadil/Papaverine Hydrochloride/Phentolamine Mesylate/Atropine Sulfate Injection, 18 mcg/1.8mg/0.2mg/0.02mg/mL, For Intracavernosal Use, Freeze, 2.5 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0547-2
by Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical
- Reason
- Lack of Assurance of Sterility
- Published
- March 11, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Mesalamine Delayed-Release Tablets, USP, 1.2 gram, 120-count bottle, Rx Only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL 33314; Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054; NDC 0591-2245-22.
by Teva Pharmaceuticals USA
- Reason
- Failed Dissolution Specifications: Low out of specification dissolution result observed during stability testing.
- Published
- March 11, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Choice Products LLC.
- Product
- Premiere Choice 3lb. Peanut Butter Cookie Dough, item 412, N…
- Reason
- Peanut Butter Cookie Dough may contain undeclared milk.
- Published
- March 11, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass III
Custom Foods LLC
- Product
- Sticky Fingers Bakeries Gluten-Free Scones, Quick & Easy Mix…
- Reason
- Firm received customer inquiry of why wheat is listed in the ingredient list of a product that is "Gluten Free".
- Published
- March 11, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Zoledronic Acid Injection 5 mg/100 mL (0.05 mg/mL), Solution for Intravenous Infusion, Sterile Solution, 100 mL Single - Dose Vial per Carton, Rx Only, Distributed by: Breckenridge Pharmaceutical, Inc., Boca Raton, FL 33487, Manufactured by: Pharmaceutics International, Inc., Hunt Valley, MD 21031, NDC 51991-064-98.
by Breckenridge Pharmaceutical, Inc
- Reason
- Failed Impurities/Degradation Specifications: Out-of-specification results obtained for impurities during stability testing.
- Published
- March 4, 2020
- Distribution
- Nationwide
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FDA Recall
Terminated
Historical recordClass I
Phenytoin Oral Suspension USP, 125 mg/5 mL potency, 8 fl oz (237 mL) Rx Only Mfd. by: Taro Pharmaceuticals Industries Ltd. Haifa Bay, Israel 2624761 Dist. by: Taro Pharmaceuticals U.S.A. Inc. Hawthorne, NY 10532, NDC 51672-4069-1
by Taro Pharmaceuticals U.S.A., Inc.
- Reason
- Resuspension Problems: Two lots of Phenytoin Oral Suspension USP 125mg/5mL may coagulate and may not resuspend as per the label copy instructions.
- Published
- March 4, 2020
- Distribution
- Nationwide
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FDA Recall
Terminated
Historical recordClass III
CVS Health Sodium Chloride Ophthalmic Ointment USP, 5%, 3.5 g tubes, Distributed By: CVS Pharmacy Inc. One CVS Drive, Woonsocket, RI 02895, NDC 59779-303-01
by Akorn, Inc.
- Reason
- Presence of Particulate Matter: Brown spots observed on the inside of the tube of product, identified as tin with trace copper, which are the base of the materials of construction for the tube.
- Published
- March 4, 2020
- Distribution
- Nationwide
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FDA Recall
Terminated
Historical recordClass III
Well at Walgreens Sodium Chloride Ophthalmic Ointment USP, 5%, 3.5 g tubes, Distributed by: Walgreen Co. 200 Wilmot Rd., Deerfield, IL 60015. NDC 0363-9050-00.
by Akorn, Inc.
- Reason
- Presence of Particulate Matter: Brown spots observed on the inside of the tube of product, identified as tin with trace copper, which are the base of the materials of construction for the tube.
- Published
- March 4, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Sodium Chloride Ophthalmic Ointment USP, 5%, 3.5 g tubes, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC 17478-622-35
by Akorn, Inc.
- Reason
- Presence of Particulate Matter: Brown spots observed on the inside of the tube of product, identified as tin with trace copper, which are the base of the materials of construction for the tube.
- Published
- March 4, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
TRAMADOL HYDROCHLORIDE Tablets, USP, 50 mg, Rx Only a)100-count bottles (NDC 60429-588-01) b) 500-count bottle (NDC 60429-588-05) Manufactured by Teva Czech Industries, s.r.o. Opava-Komarov, Czech Republic, Packaged by GSMS Incorporated, Camarillo, CA 93012
by Golden State Medical Supply Inc.
- Reason
- Labeling: Incorrect package insert - Patient leaflets for the specified lots of unscored tablets contain language relative to a 25 mg dosing titration that necessitates the use of a scored 50 mg tablet.
- Published
- March 4, 2020
- Distribution
- Nationwide
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FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Salud Natural Entrepreneur, Inc.
- Product
- Nopalina Flax Seed Fiber Capsules, 120 count bottle, UPC 8 9…
- Reason
- FDA sampling of senna leaves powder, an ingredient used to manufacture the Nopalina Flax Seed Fiber (powder) and Nopalina Flax Seed Fiber (capsules), tested positive for three types of Salmonella including Salmonella Gaminara, Salmonella Kentucky, and Salmonella Oranienburg.
- Published
- March 4, 2020
- Distribution
- Nopalina Flax Seed products are distribu…
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FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Salud Natural Entrepreneur, Inc.
- Product
- Nopalina Flax Seed Fiber in 1 and 2 lb bags, UPC 8 90523 000…
- Reason
- FDA sampling of senna leaves powder, an ingredient used to manufacture the Nopalina Flax Seed Fiber (powder) and Nopalina Flax Seed Fiber (capsules), tested positive for three types of Salmonella including Salmonella Gaminara, Salmonella Kentucky, and Salmonella Oranienburg.
- Published
- March 4, 2020
- Distribution
- Nopalina Flax Seed products are distribu…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
PNW Veg Co LLC
- Product
- Foodservice item, Norpac Catalog Number 08099, frozen FLAV-R…
- Reason
- FLAV-R-PAC Roasted Spicy Potatoes Obrien was recalled due to undeclared wheat and soy.
- Published
- March 4, 2020
- Distribution
- distributed in CA, CO, FL, IA, IL, MT, N…
View recall →
FDA Recall
Terminated
Historical recordClass III
Tramadol Hydrochloride Tablets USP CIV, 50 mg, packaged in a) 100-count bottles (NDC 0093-0058-01), b) 500-count bottles (NDC 0093-0058-05), RX only, Manufactured in Czech Republic for: Teva Pharmaceuticals USA, Inc., North Wales, PA 19545
by Teva Pharmaceuticals USA
- Reason
- Labeling: Incorrect package insert - Patient leaflets for the specified lots of unscored tablets contain language relative to a 25 mg dosing titration that necessitates the use of a scored 50 mg tablet.
- Published
- February 26, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Glycopyrrolate Tabs, USP, 1 mg, 30-count unit dose blister card, FOR INSTITUTIONAL USE ONLY, Rx Only, Packaged by Vangard, Glasgow, KY 42141; NDC 0615-8170-39.
by NCS Healthcare of Kentucky Inc
- Reason
- Failed Impurities/Degradation Specification: High Out of Specification Results for Individual Unknown Impurity.
- Published
- February 26, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Desmopressin Acetate Tablets, 0.2 mg, 30 tablets (3 x 10 unit dose blister cards), Rx Only, Packaged and distributed by: American Health Packaging, Columbus, Ohio 43217. NDC Carton: 68084-604-21; NDC Unit Dose 68084-604-11
by American Health Packaging
- Reason
- GMP Deviations: Product bottle may be absent of desiccant.
- Published
- February 26, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Desmopressin Acetate Tablets, 0.1 mg, 30 tablets (3 x 10 unit dose blister cards), Rx Only, Packaged and distributed by: American Health Packaging, Columbus, Ohio 43217. NDC Carton: 68084-606-21; NDC Unit Dose 68084-606-11
by American Health Packaging
- Reason
- GMP Deviations: Product bottle may be absent of desiccant.
- Published
- February 26, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Memantine Hydrochloride Extended-release Capsules, 28mg, packaged in 100-count Unit Dose Cartons , Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202 United States; Distributed by: Major Pharmaceuticals, 17177 N Laurel Park Dr., Suite 233, Livonia, MI 48152 USA, NDC 0904-6735-61
by The Harvard Drug Group
- Reason
- Failed Dissolution Specifications: High out of specification result observed at stability studies.
- Published
- February 26, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
CSM Bakery Products
- Product
- 22.5 lb. cases of 24 15 oz pouches CINNABON CREAM CHEESE FRO…
- Reason
- Pieces of plastic polymer were introduced into the sugar system.
- Published
- February 26, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
CSM Bakery Products
- Product
- 32 lb. pail SAFEWAY CREAM CHEESE ICING, MDM # 10203458, Dist…
- Reason
- Pieces of plastic polymer were introduced into the sugar system.
- Published
- February 26, 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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