FDA Recall
Terminated
Historical recordClass II
Metronidazole Injection, USP, 500 mg/100 mL, Rx only, Manufactured for: Claris Lifesciences Inc. North Brunswick NJ, 08902, By: Claris Injectable Ltd. Gujarat, India, NDC 36000-001-24
by Claris Lifesciences Inc
- Reason
- Lack of Assurance of Sterility: there is potential of a leak from the primary container which may result in a potential breach of sterility and contamination of the product.
- Published
- April 5, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Ciprofloxacin in Dextrose (5%) Injection, USP, 400 mg in 200 mL 5% Dextrose, Rx only, Manufactured for: Claris Lifesciences Inc. North Brunswick NJ, 08902, By: Claris Injectable Ltd. Gujarat, India, NDC 36000-009-24
by Claris Lifesciences Inc
- Reason
- Lack of Assurance of Sterility: there is potential of a leak from the primary container which may result in a potential breach of sterility and contamination of the product.
- Published
- April 5, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Sensodyne Repair & Protect Whitening, (stannous fluoride 0.45% (0.15% w/v fluoride ion)), Net Wt. 3.4 oz, Distributed by Glaxo SmithKline Consumer Healthcare LP Moon Township PA 15108 --- NDC 0135-0575-01, UPC UPC: 3 10158 84060 2
by GSK Consumer Healthcare
- Reason
- Presence of Foreign Substance; low concentration of an additional flavoring ingredient, Patchouli oil resulting in complaints of off flavor/scent
- Published
- April 5, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Atorvastatin Calcium Tablets, 10 mg*, 100-count Unit Dose Tablets (10 x 10) per carton, Rx only, Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A.., NDC 51079-208-20
by Mylan Institutional, Inc. (d.b.a. UDL Laboratories)
- Reason
- Microbial Contamination of Non-Sterile Products: potential of an elevated bioburden with identification of objectionable organisms.
- Published
- April 5, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Atorvastatin Calcium Tablets, 80 mg*, packaged in a) 90-count bottles (NDC 0378-3953-09) and b) 500-count bottles (NDC 0378-3953-07), Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A.
by Mylan Pharmaceuticals Inc.
- Reason
- Microbial Contamination of Non-Sterile Products: potential of an elevated bioburden with identification of objectionable organisms.
- Published
- April 5, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Atorvastatin Calcium Tablets, 40 mg*, packaged in a) 90-count bottles (NDC 0378-3952-09) and b) 500-count bottles (NDC 0378-3952-07); Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A.
by Mylan Pharmaceuticals Inc.
- Reason
- Microbial Contamination of Non-Sterile Products: potential of an elevated bioburden with identification of objectionable organisms.
- Published
- April 5, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Atorvastatin Calcium Tablets, 20 mg*, packaged in a) 90-count bottles (NDC 0378-3951-09) and b) 500-count bottles (NDC 0378-3951-07); Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A.
by Mylan Pharmaceuticals Inc.
- Reason
- Microbial Contamination of Non-Sterile Products: potential of an elevated bioburden with identification of objectionable organisms.
- Published
- April 5, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Atorvastatin Calcium Tablets, 10 mg*, packaged in a) 90-count bottles (NDC 0378-3950-77); b) 90-count bottles (NDC 0378-3950-09); c) 500-count bottles (NDC 0378-3950-05); d) 500-count bottles (NDC 0378-3950-07), Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A.
by Mylan Pharmaceuticals Inc.
- Reason
- Microbial Contamination of Non-Sterile Products: potential of an elevated bioburden with identification of objectionable organisms.
- Published
- April 5, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Divalproex Sodium Delayed Release Tablets, USP, 500 mg, a) 100 count (NDC 68382-033-01) and b) 500 count (NDC 68382-033-05) bottles, Rx only, manufactured by Cadila Healthcare Ltd, Ahmedabad, India, Distributed by: Zydus Pharmaceuticals, Pennington, NJ
by Zydus Pharmaceuticals USA Inc
- Reason
- Failed Dissolution Specifications; 9 month long term stability
- Published
- April 5, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Levofloxacin Injection in 5% Dextrose, 750 mg in 150 mL 5% Dextrose, Rx only, Manufactured for: Claris Lifesciences Inc. North Brunswick NJ, 08902, By: Claris Injectable Ltd. Gujarat, India, NDC 36000-048-24
by Claris Lifesciences Inc
- Reason
- Lack of Assurance of Sterility: there is potential of a leak from the primary container which may result in a potential breach of sterility and contamination of the product.
- Published
- April 5, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Fluconazole Injection, USP, 400 mg in 200 mL, Rx only, Manufactured for: Claris Lifesciences Inc. North Brunswick NJ, 08902, By: Claris Injectable Ltd. Gujarat, India, NDC 36000-003-06
by Claris Lifesciences Inc
- Reason
- Lack of Assurance of Sterility: there is potential of a leak from the primary container which may result in a potential breach of sterility and contamination of the product.
- Published
- April 5, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Grace Kennedy Foods USA LLC
- Product
- La Fe Papa Criollas Yellow Potato Net Wt. 14 oz. Distribute…
- Reason
- La Fe Papas Criollos may be contaminated with Listeria Monoctyogenes.
- Published
- April 5, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass III
Give and Go Prepared Foods Corp - Finch
- Product
- The Bakery Mini Pecan Tarts Part Platter NET WT 16x 16.2 OZ…
- Reason
- Dried weevil larvae may be present in the recalled products.
- Published
- April 5, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass III
Give and Go Prepared Foods Corp - Finch
- Product
- Two-Bite Pecan Tarts Party Platter 16 x 16.2 (460g) item num…
- Reason
- Dried weevil larvae may be present in the recalled products.
- Published
- April 5, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass III
Give and Go Prepared Foods Corp - Finch
- Product
- Two-Bite Turtle Brownie Party Platter 16 x 12.2 oz (346g) it…
- Reason
- Dried weevil larvae may be present in the recalled products.
- Published
- April 5, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass III
Give and Go Prepared Foods Corp - Finch
- Product
- Two-Bite Pecan Tart 9.2 oz (261g) item number 02023; NL Two-…
- Reason
- Dried weevil larvae may be present in the recalled products.
- Published
- April 5, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Desonide Ointment, 0.05%, NET WT 60 grams tubes, Rx only, E. FOUGERA & CO. A division of Fougera Pharmaceuticals Inc., Melville, New York 11747, NDC 0168-0309-60
by Fougera Pharmaceuticals Inc.
- Reason
- Labeling: Label Mixup; Unit boxes labeled as Desonide Ointment 0.05% may contain tubes of Desonide Ointment labeled as Ketoconazole Cream
- Published
- March 29, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Testosterone Cypionate Injection , USP, 200 mg/mL, 1 mL vial , For Intramuscular Use Only, Rx Only, Distributed by Sun Pharma Ind. Inc., NJ 08512, Manufactured by Sun Pharma Ind. Ltd. India, NDC 62756-015-40
by Sun Pharmaceutical Industries, Inc.
- Reason
- Presence of Particulate Matter
- Published
- March 29, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Famciclovir tablets, 500 mg, packaged in 30-count unit dose cartons, Rx only, Manufactured for: AvKARE, Inc., Pulaski, TN 38478, NDC 50268-307-13
by AVKARE Inc.
- Reason
- Failed impurities/ degradation specifications: Product was above specification for unknown impurities.
- Published
- March 29, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Quillivant XR (methylphenidate HCl) for extended-release oral suspension, 900 mg/180 mL (25mg/5mL), Rx Only, Distributed by: NextWave Pharmaceuticals, Inc. A subsidiary of Pfizer Inc, New York, NY 10017 Manufactured by: Tris Pharma, Inc., Monmouth Junction, NJ 08852 (NDC 24478-190-30).
by PFIZER INC
- Reason
- Failed Dissolution Specifications: Dissolution at 8 hour was out of specification at 12 month at 25 degree Celsius.
- Published
- March 29, 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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