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 I
Butala Emporium, Inc.
- Product
- Baidyanath brand Chitrakadi Bati, Dietary Supplement, 80 Ta…
- Reason
- The dietary supplements were found to contain lead, mercury and/or arsenic at levels exceeding permissible limits.
- Published
- April 5, 2017
- Distribution
- NY (via 3 retail stores) and directly to…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Butala Emporium, Inc.
- Product
- Baidyanath brand Gaisantak Bati, Dietary Supplement, 80 Tab…
- Reason
- The dietary supplements were found to contain lead, mercury and/or arsenic at levels exceeding permissible limits.
- Published
- April 5, 2017
- Distribution
- NY (via 3 retail stores) and directly to…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Butala Emporium, Inc.
- Product
- Baidyanath brand Brahmi Bati, Dietary Supplement, 80 Tablet…
- Reason
- The dietary supplements were found to contain lead, mercury and/or arsenic at levels exceeding permissible limits.
- Published
- April 5, 2017
- Distribution
- NY (via 3 retail stores) and directly to…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Butala Emporium, Inc.
- Product
- Baidyanath brand Arogyavardhini Bati, Dietary Supplement, 80…
- Reason
- The dietary supplements were found to contain lead, mercury and/or arsenic at levels exceeding permissible limits.
- Published
- April 5, 2017
- Distribution
- NY (via 3 retail stores) and directly to…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Butala Emporium, Inc.
- Product
- Baidyanath brand Agnitundi Bati, Dietary Supplement, 80 Tab…
- Reason
- The dietary supplements were found to contain lead, mercury and/or arsenic at levels exceeding permissible limits.
- Published
- April 5, 2017
- Distribution
- NY (via 3 retail stores) and directly to…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Butala Emporium, Inc.
- Product
- Baidyanath brand Marichyadi Bati, Dietary Supplement, 80 Ta…
- Reason
- The dietary supplements were found to contain lead, mercury and/or arsenic at levels exceeding permissible limits.
- Published
- April 5, 2017
- Distribution
- NY (via 3 retail stores) and directly to…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Butala Emporium, Inc.
- Product
- Baidyanath brand Shankh Bati, Dietary Supplement, 80 Tablet…
- Reason
- The dietary supplements were found to contain lead, mercury and/or arsenic at levels exceeding permissible limits.
- Published
- April 5, 2017
- Distribution
- NY (via 3 retail stores) and directly to…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Butala Emporium, Inc.
- Product
- Baidyanath brand Saptamrit Lauh, Dietary Supplement, 80 Tab…
- Reason
- The dietary supplements were found to contain lead, mercury and/or arsenic at levels exceeding permissible limits.
- Published
- April 5, 2017
- Distribution
- NY (via 3 retail stores) and directly to…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Butala Emporium, Inc.
- Product
- Baidyanath brand Rajahpravartini Bati, Dietary Supplement, 8…
- Reason
- The dietary supplements were found to contain lead, mercury and/or arsenic at levels exceeding permissible limits .
- Published
- April 5, 2017
- Distribution
- NY (via 3 retail stores) and directly to…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Butala Emporium, Inc.
- Product
- Baidyanath brand Sarivadi Bati, Dietary Supplement, 80 Tabl…
- Reason
- The dietary supplements were found to contain lead, mercury and/or arsenic at levels exceeding permissible limits .
- Published
- April 5, 2017
- Distribution
- NY (via 3 retail stores) and directly to…
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 →
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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