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 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
Suja Life LLC
- Product
- Suja Organic Tropical Dragon Fruit + Veggie Smoothie, 12 oz.…
- Reason
- Firm was notified by supplier of an unapproved herbicide in raw material, flax, that was used in their juice product.
- Published
- February 26, 2020
- Distribution
- One consignee with distribution centers…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Suja Life LLC
- Product
- Suja Organic Mango Mojito Fruit + Veggie Smoothie, 12 oz. U…
- Reason
- Firm was notified by supplier of an unapproved herbicide in raw material, flax, that was used in their juice product.
- Published
- February 26, 2020
- Distribution
- One consignee with distribution centers…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Suja Life LLC
- Product
- Suja Organic Ginger Bliss Fruit + Veggie Smoothie, 12 oz. U…
- Reason
- Firm was notified by supplier of an unapproved herbicide in raw material, flax, that was used in their juice product.
- Published
- February 26, 2020
- Distribution
- One consignee with distribution centers…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Suja Life LLC
- Product
- Suja Organic Berry Zest Fruit + Veggie Smoothie, 12 oz. UPC…
- Reason
- Firm was notified by supplier of an unapproved herbicide in raw material, flax, that was used in their juice product.
- Published
- February 26, 2020
- Distribution
- One consignee with distribution centers…
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 →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
CSM Bakery Products
- Product
- 18 lb. pail READY ICE FUDGE ICING, MDM # 10202894, Manufactu…
- 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
- 14 lb. pail PINK DECORATING BUTTERCREME FROSTING, MDM # 1020…
- 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
- 18 lb. pail SIMPLICIOUS CREAM CHEESE ICING 18#PL, MDM # 1020…
- 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
- 45 lb. box SAFEWAY CHOCOLATE BUTTERCREME BASE, MDM # 1020186…
- 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 GLOSSY WHITE ICING (1102507) donut icing, 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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