FDA Recall
Terminated
Historical recordClass III
Fluconazole Injection, USP, Iso-Osmotic Sodium Chloride Diluent, 200 mg in 100 mL (2 mg/mL), 100 mL Single Dose Flexible Container bag, Rx only, Manufactured for: Claris Lifesciences Inc., North Brunswick, NJ 08902; By: Claris Injectables Ltd., Gujarat, India, NDC a) 36000-002-10 and b) 36000-002-06.
by Renaissance Lakewood, LLC
- Reason
- Superpotent Drug: lots out of specification for elevated sodium chloride and fluconazole assay.
- Published
- August 8, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Fluconazole Injection, USP, Iso-Osmotic Sodium Chloride Diluent, 200 mg in 100 mL (2 mg/mL), 100 mL Single Dose Flexible Container bag, Rx only, Manufactured for: Claris Lifesciences Inc., North Brunswick, NJ 08902; By: Claris Injectables Ltd., Gujarat, India, NDC 36000-002-10.
by Renaissance Lakewood, LLC
- Reason
- Failed Stability Specifications: lot out of specification for elevated water vapor.
- Published
- August 8, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Fluconazole Injection, USP, Iso-Osmotic Sodium Chloride Diluent, 400 mg in 200 mL (2 mg/mL), 200 mL Single Dose Flexible Container bag, Rx only, Manufactured for: Claris Lifesciences Inc., North Brunswick, NJ 08902; By: Claris Injectables Ltd., Gujarat, India; NDC 36000-003-06.
by Renaissance Lakewood, LLC
- Reason
- Superpotent Drug and Failed Stability Specifications: lot out of specification for elevated sodium chloride and elevated water vapor.
- Published
- August 8, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Doxycycline Hyclate Tablets, USP, 100 mg, Rx Only, 30 tablets, 3 x 10 unit dose Cartons, Mfd. by: West-Ward Pharmaceuticals Corp., Eatontown, NY 07724; Distributed by: Major Pharmaceuticals, 17177 N. Laurel Park Dr., Suite 233, Livonia, MI 48152 USA. NDC: 0904-0430-04
by MAJOR PHARMACEUTICALS
- Reason
- Failed Dissolution Specifications
- Published
- August 8, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Doxycycline Hyclate Tablets, USP, 100 mg*. 500-count bottle, Rx only. Manufactured by: West-Ward Pharmaceuticals Corp. Eatontown, NJ 07724. NDC# 0143-2112-05.
by West-Ward Columbus Inc
- Reason
- Failed Dissolution Specifications:
- Published
- August 8, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Doxycycline Hyclate Tablets, USP, 100 mg*. 50-count bottle, Rx only. Manufactured by: West-Ward Pharmaceuticals Corp. Eatontown, NJ 07724. NDC# 0143-2112-50.
by West-Ward Columbus Inc
- Reason
- Failed Dissolution Specifications:
- Published
- August 8, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Daptomycin for Injection, 500 mg per vial, packaged as 1 Single-dose vial per carton, Rx only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-0106-01.
by Pfizer
- Reason
- Microbial Contamination of Sterile Products: Product associated with reports of adverse events indicative of infusion reactions related to microbiological contamination.
- Published
- August 8, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Indomethacin Capsules, USP, 50 mg, 100-count bottles, Rx only, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854; By: Hetero, Hetero Labs Limited, Jeedimetla, Hyderabad - 500 055, India; NDC 31722-543-01.
by Hetero Labs, Ltd. - Unit III
- Reason
- Failed Tablet/Capsule Specifications: customer complaints of deformed, clumped, misshaped, melted or stuck together capsules.
- Published
- August 8, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Griffith Labs U.S.A.
- Product
- Garlic Cheese Crouton Seasoning 50 pound bag Item 8590862…
- Reason
- Potential presence of Salmonella due to use of recalled whey ingredient
- Published
- August 8, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Griffith Labs U.S.A.
- Product
- Deep Pan Pizza Dough 1 pound 4 oz bag, 24 units per carton…
- Reason
- Potential presence of Salmonella due to use of recalled whey ingredient
- Published
- August 8, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Griffith Labs U.S.A.
- Product
- Cold Dough Premix 6.8 pound bag, 6 units per carton Item 1…
- Reason
- Potential presence of Salmonella due to use of recalled whey ingredient
- Published
- August 8, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass III
New Seasons Market LLC
- Product
- Cauliflower Pilaf with Fresh Turmeric and Fennel, New Season…
- Reason
- Cauliflower Pilaf meal kit is recalled because the Almonds container, packaged in a separate clear containers inside the kit, was mislabeled with a sticker that declares peanut.
- Published
- August 8, 2018
- Distribution
- distributed in OR and WA
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Griffith Labs U.S.A.
- Product
- Seasoned Crouton Seasoning N5 50 pound bag Item 100001114…
- Reason
- Potential presence of Salmonella due to use of recalled whey ingredient
- Published
- August 8, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Griffith Labs U.S.A.
- Product
- Romano Garlic Seasoning 50 pound bag Item 1000015205
- Reason
- Potential presence of Salmonella due to use of recalled whey ingredient
- Published
- August 8, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Griffith Labs U.S.A.
- Product
- Onion Garlic Seasoning 50 pound bag Item 1000025776
- Reason
- Potential presence of Salmonella due to use of recalled whey ingredient
- Published
- August 8, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Griffith Labs U.S.A.
- Product
- Italian Crouton Seasoning 50 pound bag Item 1000012969
- Reason
- Potential presence of Salmonella due to use of recalled whey ingredient
- Published
- August 8, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Griffith Labs U.S.A.
- Product
- Italian Crouton Seasoning 50 pound bag Item 1000017039
- Reason
- Potential presence of Salmonella due to use of recalled whey ingredient
- Published
- August 8, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Griffith Labs U.S.A.
- Product
- Herb Crouton Seasoning 50 pound bag Item 859021000
- Reason
- Potential presence of Salmonella due to use of recalled whey ingredient
- Published
- August 8, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Griffith Labs U.S.A.
- Product
- Herb Crouton Seasoning 50 pound bag Item 702046300
- Reason
- Potential presence of Salmonella due to use of recalled whey ingredient
- Published
- August 8, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Griffith Labs U.S.A.
- Product
- Garlic Parmesan 50 pound bag Item 859075900
- Reason
- Potential presence of Salmonella due to use of recalled whey ingredient
- Published
- August 8, 2018
- 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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