FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Houdini Inc.
- Product
- Tis The Season gift basket, Item No. 1084804
- Reason
- Potential Salmonella contamination.
- Published
- February 8, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Houdini Inc.
- Product
- Wooden Centerpiece gift basket, Item No. 1080571
- Reason
- Potential Salmonella contamination.
- Published
- February 8, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Houdini Inc.
- Product
- Houdini Fabric gift basket, Item No. 1072552
- Reason
- Potential Salmonella contamination.
- Published
- February 8, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Houdini Inc.
- Product
- Vintners Path Chardonnay Seasons Greetings Basket #795
- Reason
- Potential Salmonella contamination.
- Published
- February 8, 2017
- Distribution
- Nationwide
View recall →
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 →
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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