FDA Recall
Terminated
Historical recordClass III
Azelastine Hydrochloride Nasal Solution (Nasal Spray), 0.1% (137 mcg per spray), packaged in 30 mL bottles, Rx only, Distributed by: West-Ward Pharmaceuticals Corp., Eatontown, NJ 07724, NDC 0054-0293-99
by Roxane Laboratories, Inc.
- Reason
- Defective Delivery System: out of specification result for droplet size distribution at the d90 measurement testing during the 6 month time point..
- Published
- February 1, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
buPROPion Hydrochloride Extended-release Tablets, USP (SR), 200 mg, 60 count bottles, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol-389 350, Gujarat, India NDC 47335-0738-86
by Sun Pharmaceutical Industries, Inc.
- Reason
- Failed Dissolution Specifications; 18 month stability time point
- Published
- February 1, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
buPROPion Hydrochloride Extended-release Tablets, USP (SR), 150 mg, a) 60 (NDC 47335-737-86), b) 100 (NDC 47335-737-88) and c) 500 (NDC 47335-737-13) count bottles, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol-389 350, Gujarat, India
by Sun Pharmaceutical Industries, Inc.
- Reason
- Failed Dissolution Specifications; 18 month stability time point
- Published
- February 1, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Temozolomide Capsules, 250 mg, 5-count bottles, Rx only, Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 USA, NDC 0378-5265-98.
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 II
Temozolomide Capsules, 180 mg, packaged in a) 5-count bottles (NDC 0378-5264-98), b) 14-count bottles (NDC 0378-5264-14), 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 II
Temozolomide Capsules, 140 mg, packaged in a) 5-count bottles (NDC 0378-5263-98), b) 14-count bottles (NDC 0378-5263-14), 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 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
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 II
Herr Foods, Inc.
- Product
- Dried Smoke Chipotle Flavored Kettle Cooked Potato Chips 2.…
- Reason
- Herrs Foods is announcing a product recall on Chipotle flavored Kettle Potato Chips under the Herrs and the Peddlers Pantry Brand, 2.0 oz. due to possible health risk. These products were flavored with Chipotle seasoning that contained a milk ingredient . The milk ingredient is being recalled due to a potential risk of Salmonella contamination.
- Published
- January 25, 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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