FDA Recall
🇺🇸 United States
TerminatedTerminated: October 16, 2017Historical recordClass II
GOULIBEUR
- Product
- Goulibeur 2 pure butter shortbreads in a freshness bag Ne…
- Reason
- This recall has been initiated due to missing information about the presence of the milk allergen in the list of ingredients. It is written that the products contain butter, but the food source for this ingredient (milk) is not indicated.
- Published
- March 22, 2017
- Distribution
- U.S.: Maryland
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FDA Recall
🇺🇸 United States
TerminatedTerminated: October 16, 2017Historical recordClass II
GOULIBEUR
- Product
- Goulibeur- Cube tin box Life in Paris, containing mini heart…
- Reason
- This recall has been initiated due to missing information about the presence of the milk allergen in the list of ingredients. It is written that the products contain butter, but the food source for this ingredient (milk) is not indicated.
- Published
- March 22, 2017
- Distribution
- U.S.: Maryland
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FDA Recall
🇺🇸 United States
TerminatedTerminated: October 16, 2017Historical recordClass II
GOULIBEUR
- Product
- Goulibeur - Large French walnut shortbread, in paper carton…
- Reason
- This recall has been initiated due to missing information about the presence of the milk allergen in the list of ingredients. It is written that the products contain butter, but the food source for this ingredient (milk) is not indicated.
- Published
- March 22, 2017
- Distribution
- U.S.: Maryland
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FDA Recall
🇺🇸 United States
TerminatedTerminated: October 16, 2017Historical recordClass II
GOULIBEUR
- Product
- Goulibeur - Pack of 15 pure butter shortbreads in 3 freshnes…
- Reason
- This recall has been initiated due to missing information about the presence of the milk allergen in the list of ingredients. It is written that the products contain butter, but the food source for this ingredient (milk) is not indicated.
- Published
- March 22, 2017
- Distribution
- U.S.: Maryland
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FDA Recall
🇺🇸 United States
TerminatedTerminated: October 16, 2017Historical recordClass II
GOULIBEUR
- Product
- Goulibeur Cube tin box with pictures of France, containing…
- Reason
- This recall has been initiated due to missing information about the presence of the milk allergen in the list of ingredients. It is written that the products contain butter, but the food source for this ingredient (milk) is not indicated.
- Published
- March 22, 2017
- Distribution
- U.S.: Maryland
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FDA Recall
🇺🇸 United States
TerminatedTerminated: October 16, 2017Historical recordClass II
GOULIBEUR
- Product
- Goulibeur - Large pure butter shortbread with flaked almonds…
- Reason
- This recall has been initiated due to missing information about the presence of the milk allergen in the list of ingredients. It is written that the products contain butter, but the food source for this ingredient (milk) is not indicated.
- Published
- March 22, 2017
- Distribution
- U.S.: Maryland
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FDA Recall
🇺🇸 United States
TerminatedTerminated: June 25, 2018Historical recordClass I
Kingsway Trading Inc
- Product
- Xanthium & Siler Combo (Bi Yan Pian) DIETARY SUPPLEMENT, Net…
- Reason
- Presence of Ephedrae Herba (ma huang), a FDA Banned Ephedra Alkaloid
- Published
- March 22, 2017
- Distribution
- MA, NJ, NY, IL, MD, FL, MO, TX, IN, GA,…
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FDA Recall
TerminatedTerminated: October 24, 2017Historical recordClass II
Pioglitazone and Glimepiride Tablets, USP, 30 mg/4 mg, 30 count bottles, Rx only, Manufactured by Lek Pharmaceuticals d.d., Verovskova Ulica 57, Ljubljana, - SI-1526, Slovenia --- NDC 0781-5635-31
by Sandoz Inc
- Reason
- Failed Dissolution Specifications
- Published
- March 15, 2017
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: January 9, 2018Historical recordClass III
Levofloxacin Ophthalmic Solution, 0.5%, Sterile, packaged in 5mL bottles, Rx Only, Manufactured by Hi-Tech Pharmacal Co., Inc., Amityville, NY 11707, NDC 50383-283-05
by Actavis Inc
- Reason
- Failed Impurities/ Degradation Specifications: OOS for related compound (levofloxacin n-oxide) at the 18 month stability time point.
- Published
- March 15, 2017
- Distribution
- Nationwide
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FDA Recall
CompletedHistorical recordClass II
Aspirin Chewable Tablets, 81 mg, (NSAID*), packaged in UD 750 Tablets (25 x 30) tablets in blisters per carton, Dist. By: McKesson Packaging Services, a business unit of McKesson Corporation, 7101 Weddington Rd., Concord, NC 28027, NDC 63739-434-01.
by Mckesson Packaging Services
- Reason
- Presence of Foreign Substance: foreign material found in the bulk inventory.
- Published
- March 15, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: June 12, 2018Historical recordClass II
Edex (alprostadil for injection) 10mcg, packaged in a 2 pack carton, Rx only, Manufactured in Germany for: Actient Pharmaceuticals, LLC, Lake Forest, Illinois 60045; NDC 52244-010-02.
by Endo Pharmaceuticals, Inc.
- Reason
- Lack of Assurance of Sterility: Defective container resulting in the lack of sterility assurance. ok thanks
- Published
- March 15, 2017
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: February 5, 2018Historical recordClass III
Risedronate Sodium Delayed-release Tablets, 35 mg, Once-a-Week, 1 tablet per blister (NDC 0093-5509-19), packaged in 4 blisters per carton (NDC 0093-5509-44), Rx only, TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454.
by Teva Pharmaceuticals USA
- Reason
- Failed Dissolution Specifications: low out of specification dissolution results found during stability testing.
- Published
- March 15, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: January 24, 2018Historical recordClass II
Calcipotriene Cream 0.0005%, packaged in a) 60g tube, (NDC 66993-877-61), b) 120g tube (NDC 66993-877-78), Rx Only, Manufactured by: LEO Pharma Inc., Dublin, Ireland, Manufactured for: Prasco Laboratories, Mason, OH, 45040
by LEO PHARMA INC
- Reason
- Incorrect/Undeclared excipients: inadvertent omission of a drug excipient from the the Authorized Generic label and also a warning regarding contact dermatitis from the brand product labeling not being incorporated into the Authorized Generic labeling.
- Published
- March 15, 2017
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: March 15, 2019Historical recordClass II
Mirtazapine Tablets, USP, 45 mg. Rx only, 100 Tablets (10 X 10). Manufactured by: Mylan Pharmaceuticals Inc, Morgantown, WV ---NDC 51079-088-20
by Mylan Institutional, Inc. (d.b.a. UDL Laboratories)
- Reason
- Presence of Foreign Tablets/Capsules; possibility of Glipizide 10 mg tablets commingled
- Published
- March 15, 2017
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: July 12, 2017Historical recordClass II
Mirtazapine Tablets, USP 45 mg, a) 30 count, b) 100 count and c) 500 count bottles, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV
by Mylan Pharmaceuticals Inc.
- Reason
- Presence of Foreign Tablets/Capsules; possibility of Glipizide 10 mg tablet in bottle
- Published
- March 15, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: March 16, 2017Historical recordClass II
Versa Marketing
- Product
- Fusia Asian Aspirations Szechuan Stir Fry; A delicious blen…
- Reason
- Product was tested and found positive for Listeria monocytogenes.
- Published
- March 15, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: June 5, 2017Historical recordClass II
Trader Joes Company
- Product
- Trader Joes Imported English Authentic Lemon Curd, 10.5oz (…
- Reason
- Trader Joe's Co. is recalling the Lemon Curd because it contains undeclared milk in the sub-ingredient of butter.
- Published
- March 15, 2017
- Distribution
- US: CA, OR, AZ, WA, NV, NM, CO, UT, ID,…
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: August 22, 2017Historical recordClass II
Nu Skin Enterprises Inc.
- Product
- Pharmanex Cholestin. Cholesterol Health. 60 Softgels.
- Reason
- Nu Skin announces a voluntary field action for Pharmanex Cholestin due to undeclared allergen; soy.
- Published
- March 15, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: August 22, 2017Historical recordClass II
Nu Skin Enterprises Inc.
- Product
- Pharmanex Cortitrol. Cortisol Management. 60 Capsules
- Reason
- Nu Skin announces a voluntary field action for Pharmanex Cortitrol due to undeclared allergen; soy.
- Published
- March 15, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: August 22, 2017Historical recordClass II
Nu Skin Enterprises Inc.
- Product
- Pharmanex BioGinkgo. Mental Sharpness. 60 Tablets
- Reason
- Nu Skin announces a voluntary field action for Pharmanex BioGinkgo due to undeclared allergen; wheat.
- Published
- March 15, 2017
- 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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