FDA Recall
Terminated
Historical recordClass II
Temozolomide Capsules, 100 mg, packaged in a) 5-count bottles (NDC 0378-5262-98), b) 14-count bottles (NDC 0378-5262-14), Rx only, Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 USA.
by Mylan LLC.
- Reason
- Failed Tablet/Capsule Specifications: customer complaints of broken or crushed capsules, resulting in loose powder in the bottle.
- Published
- February 1, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Albuterol Sulfate Inhalation Solution, USP, 0.021% (0.63 mg / 3 mL), 3mL Vials, Rx only, Mfd. for Watson Laboratories Inc., Corona, CA 92880 USA, Mfd. by Cipla Ltd. Verna, Goa India, NDC 0591-3467-53
by Actavis Inc
- Reason
- Failed Impurities/Degradation Specifications: Product is out of specification for a known degradant.
- Published
- February 1, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
DEXAMETHASONE ELIXIR, USP, 0.5 mg/5 mL, 8 fl.oz., Rx only, Manufactured for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL, NDC 0603-1147-56
by Vintage Pharmaceuticals LLC dba Qualitest Pharmaceuticals
- Reason
- Failed Impurities/ Degradation Specifications
- Published
- February 1, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Furosemide Tablets USP, 20 mg, 1000 count bottles, Rx only, Roxane Laboratories, Inc., Columbus, Ohio 43216, NDC 0054-4297-31.
by Roxane Laboratories, Inc.
- Reason
- Failed Tablet/Capsule Specifications: An unusually thick tablet was reported through a complaint.
- Published
- February 1, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Boulder Brands, LLC
- Product
- Earth Balance Vegan Cheddar flavored Mac and Cheese, 6oz pac…
- Reason
- Earth Balance Vegan White Cheddar flavored Mac and Cheese and Earth Balance Vegan Cheddar flavored Mac and Cheese with undeclared allergen, milk.
- Published
- February 1, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Boulder Brands, LLC
- Product
- Earth Balance Vegan White Cheddar flavored Mac and Cheese, 6…
- Reason
- Earth Balance Vegan White Cheddar flavored Mac and Cheese and Earth Balance Vegan Cheddar flavored Mac and Cheese with undeclared allergen, milk.
- Published
- February 1, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Berner Food & Beverage, LLC
- Product
- Our Family Alfredo, Pasta Sauce; NET WT. 15 OZ, CONT. NET 42…
- Reason
- Product contaminated with spoilage bacteria, Enterobacter cloacae and Pantoea species.
- Published
- February 1, 2017
- Distribution
- Multiple states
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Berner Food & Beverage, LLC
- Product
- Roasted Garlic Alfredo, Pasta Sauce; NET WT. 15 OZ, CONT. NE…
- Reason
- Product contaminated with spoilage bacteria, Enterobacter cloacae and Pantoea species.
- Published
- February 1, 2017
- Distribution
- Multiple states
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Berner Food & Beverage, LLC
- Product
- Four Cheese Alfredo, Pasta Sauce; NET WT. 15 OZ, CONT. NET 4…
- Reason
- Product contaminated with spoilage bacteria, Enterobacter cloacae and Pantoea species.
- Published
- February 1, 2017
- Distribution
- Multiple states
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Berner Food & Beverage, LLC
- Product
- Creamy Alfredo, Pasta Sauce; NET WT. 15 OZ, CONT. NET 425g;…
- Reason
- Product contaminated with spoilage bacteria, Enterobacter cloacae and Pantoea species.
- Published
- February 1, 2017
- Distribution
- Multiple states
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Berner Food & Beverage, LLC
- Product
- Lite Creamy Alfredo, gluten free, Pasta Sauce; Glass jar, me…
- Reason
- Product contaminated with spoilage bacteria, Enterobacter cloacae and Pantoea species.
- Published
- February 1, 2017
- Distribution
- Multiple states
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Schreiber Food International
- Product
- Ambrosia Quality Foods Brand 4/1 gallon Worcestershire Sauce…
- Reason
- Ambrosia brand 4/1 Gallon Worcestershire Sauce may contain undeclared peanuts.
- Published
- February 1, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
HCG (Chorionic Gonadotropin Lyopholized) II, 1000 unit vial, Rx only, Prepared by Town & Country, Compounding & Consultation Services, 106 Prospect St - 1st FL, Ridgewood, NJ 07459
by Town and Country Compounding and Consultation Services, LLC
- Reason
- Subpotent Drug: due to failed potency results of 74% (spec. 80-125%).
- Published
- January 25, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Donepezil Hydrochloride Tablets, 10 mg, packaged in a) 30-count bottles (NDC 0781-5275-31) and b) 1000-count bottles (NDC 0781-5275-10), Rx only, Manufactured in India by Sandoz Private Ltd for Sandoz Inc., Princeton, NJ 08540.
by Sandoz Inc
- Reason
- Subpotent Drug: out of specification results for assay test.
- Published
- January 25, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/5%, 45 g tubes, Rx Only, Manufactured by Perrigo, Yeruham, Israel, Distributed by Perrigo, Allegan, MI --- NDC 45802-736-84, UPC 345802736840
by L. Perrigo Company
- Reason
- Microbial Contamination of Non-Sterile Product; small number of tubes may include the presence of mold on the cap
- Published
- January 25, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Novacort Gel Sample Packets (2% hydrocortisone acetate, 1% pramoxine HCl), 10-count Carton of 1.0 g sample packets), NDC 69646-704-38 (10 ct. Carton of 1gm samples) / NDC 69646-704-01 (Individual 1gm Samples within Carton), Rx Only, Novum Pharma LLC, Chicago, IL 60654
by Novum Pharma, LLC
- Reason
- Subpotent Drug: Out of specification result for pramoxine hydrochloride
- Published
- January 25, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Pentasa (mesalamine) Controlled-Release Capsules, 250 mg, 240 count bottle, Rx only, Manufactured for Shire US Inc., Lexington, MA --- NDC 54092-189-81
by Shire PLC
- Reason
- Presence of Foreign Tablets/Capsules; 500 mg capsules were found in bottles labeled to contain 250 mg capsules
- Published
- January 25, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical 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
- Published
- January 25, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Aspen Hills, Inc.
- Product
- Peanut Butter Cookie Dough Item 06-371, NET WT. 30 lbs (13.6…
- Reason
- Product potentially contaminated with Listeria monocytogenes
- Published
- January 25, 2017
- Distribution
- Recalled product was distributed to the…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Aspen Hills, Inc.
- Product
- GMO Free Cookie Dough 03-377, NET WT. 30 lbs (13.61 Kg) Aspe…
- Reason
- Product potentially contaminated with Listeria monocytogenes
- Published
- January 25, 2017
- Distribution
- Recalled product was distributed to the…
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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