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
View recall →
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
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass III
Paleonola Llc
- Product
- Paleonola Grain Free Granola; Pumpkin Pie; packaged in 10oz…
- Reason
- Potentially contaminated with an unapproved herbicide, haloxyfop.
- Published
- March 4, 2020
- Distribution
- Multiple states
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass III
Paleonola Llc
- Product
- Paleonola Grain Free Granola; Apple Pie; packaged in 10oz st…
- Reason
- Potentially contaminated with an unapproved herbicide, haloxyfop.
- Published
- March 4, 2020
- Distribution
- Multiple states
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass III
Paleonola Llc
- Product
- Paleonola Grain Free Granola; Chocolate Fix; packaged in 10o…
- Reason
- Potentially contaminated with an unapproved herbicide, haloxyfop.
- Published
- March 4, 2020
- Distribution
- Multiple states
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass III
Paleonola Llc
- Product
- Paleonola Grain Free Granola; Pina Colada; packaged in 10oz…
- Reason
- Potentially contaminated with an unapproved herbicide, haloxyfop.
- Published
- March 4, 2020
- Distribution
- Multiple states
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass III
Paleonola Llc
- Product
- Paleonola Grain Free Granola; Maple Pancake; packaged in 10o…
- Reason
- Potentially contaminated with an unapproved herbicide, haloxyfop.
- Published
- March 4, 2020
- Distribution
- Multiple states
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass III
Paleonola Llc
- Product
- Paleonola Grain Free Granola; The Original; packaged in 10oz…
- Reason
- Potentially contaminated with an unapproved herbicide, haloxyfop.
- Published
- March 4, 2020
- Distribution
- Multiple states
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
CJ Foods Inc., A Division of CJ America
- Product
- Annie Chun's Japanese Style Teriyaki Noodle Bowl with Cooked…
- Reason
- Pad Thai Noodle Bowl which contains peanuts was packaged with the sleeve for Teriyaki Noodle Bowl leaving undeclared peanuts on the product label.
- Published
- March 4, 2020
- Distribution
- WA, RI, CA, FL, TN, PA, MN, IL, WI, and…
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 →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
CSM Bakery Products
- Product
- 43 lb. pail WHITE 'N GLOSSY ICING donut icing, MDM # 1020328…
- 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
- 35 lb. pail VANILLA XTRA SMOOTH BUTTERCREME FROSTING, MDM #…
- 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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