FDA Recall
Terminated
Historical recordClass II
Fentanyl Citrate Inj., USP 100 mcg Fentanyl/2 mL (50 mcg/mL), 2 mL Single-dose Vial, Each Tray contains 25 Vials, Intravenous or Intramuscular Use, Rx only, Distributed by Hospira, Inc. Lake Forest, IL 60045, NDC 00409-9094-12 (vial), 00409-9094-22 (tray).
by Pfizer Inc.
- Reason
- Defective Container: confirmed customer reports for vials with loose metal overseal crimp defects, which may result in lack of assurance of sterility.
- Published
- February 19, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Ethacrynate Sodium for Injection, USP, 50mg/vial, Single Dose Vial, Rx Only, Manufactured by: Cadila Healthcare Limited, Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 68382-246-01.
by Zydus Pharmaceuticals USA Inc
- Reason
- cGMP Deviations
- Published
- February 19, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
Lamotrigine Tablets, USP, 100 mg, Rx Only, 100-count bottle, Mfd. by: Taro Pharmaceutical Industries Ltd. Haifa Bay, Israel 2624761 Dist. by: Taro Pharmaceuticals U.S.A., Inc. Hawthorne, NY 10532, NDC 51672-4131-1.
by Taro Pharmaceuticals U.S.A., Inc.
- Reason
- Cross Contamination; Lamotrigine Tablets 100 mg USP was contaminated with enalapril maleate.
- Published
- February 19, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Completed
Historical recordClass II
Market America Inc
- Product
- bliss anti-stress formula Dietary Supplement, 60 Tablets; Ma…
- Reason
- Potentially undeclared Yohimbe 83 and complaints of adverse reactions: upset stomach, jittery, sweaty, lightheaded or dizzy.
- Published
- February 19, 2020
- Distribution
- Product was shipped to the following sta…
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FDA Recall
Terminated
Historical recordClass III
Pioglitazone and Metformin Hydrochloride Tablets, USP 15 mg/500 mg, Rx Only, 60-count bottle, Manufactured for Macleods Pharma USA, Inc. Plainsboro, NJ 08536, Manufactured by: Macleods Pharmaceuticals Ltd. Baddi, Himachal Pradesh, India, NDA 33342-176-09
by Macleods Pharma Usa Inc
- Reason
- Subpotent Drug: Out of specification assay result, below specification, for two lots of Pioglitazone And Metformin Hydrochloride Tablets.
- Published
- February 12, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Atorvastatin Calcium Tablets, USP, 10 mg*, 90-count bottle, Rx Only, Manufactured for: Biocon Pharma Inc., Iselin, NJ 08830-3009 USA; Manufactured By: Graviti Pharmaceuticals Pvt. Ltd., Telangana -502307, INDIA; NDC 70377-027-11.
by Graviti Pharmaceuticals Private Limited
- Reason
- Presence of Foreign Tablets/Capsules: Customer complaint that one 20 mg Atorvastatin Calcium Tablet was present in a bottle labeled as and containing eight-nine Atorvastatin Calcium Tablets, USP 10 mg.
- Published
- February 12, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Desmopressin Acetate Tablets, 0.2 mg, 100-count bottle, Rx Only, Manufactured by: Actavis Laboratories, Inc. Fort Lauderdale, FL 33314 USA, Distributed by: Actavis Pharma, Inc. Parisppany, NJ 07054 USA, NDC 0591-2465-01
by Teva Pharmaceuticals USA
- Reason
- GMP Deviations: Product bottle may be absent of desiccant.
- Published
- February 12, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Desmopressin Acetate Tablets, 0.1 mg, 100-count bottle, Rx Only, Manufactured by: Actavis Laboratories, Inc. Fort Lauderdale, FL 33314 USA, Distributed by: Actavis Pharma, Inc. Parisppany, NJ 07054 USA, NDC 0591-2464-01
by Teva Pharmaceuticals USA
- Reason
- GMP Deviations: Product bottle may be absent of desiccant.
- Published
- February 12, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Clonidine Hydrochloride Tablets, USP 0.1mg, Rx Only, 100-count bottle, Manufactured by: Unichem Laboratories Ltd. Pilerne Ind. Estate, Pilerne Bardez, Goa 403 511 India. Manufactured for: Unichem Pharmaceuticals (USA), Inc. East Brunswick, NJ 08816. NDC 29300-135-01
by UNICHEM PHARMACEUTICALS USA INC
- Reason
- Failed Impurities/Degredation Specifications: This recall is initiated as a precautionary measure due to potential migration of Benzophenone at very low level into product from container label.
- Published
- February 12, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Olmesartan Medoxomil Tablets 20 mg, Rx Only, 90 Tablets per Bottle, Manufactured by: Alkem Laboratories Ltd., Mumbai - 400 013 INDIA, Distributed by: Ascend Laboratories, LLC Parsippany, NJ 07054, NDC 67877-446-90.
by Ascend Laboratories LLC
- Reason
- cGMP Deviations; Olmesartan Medoximil Tablets 20 mg was released in error with alternate API source prior to filing and approval of Prior Approval Supplement.
- Published
- February 12, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Minocycline Hydrochloride Extended-Release Tablets, USP, 105 mg*, 30-count bottle, Rx Only, Manufactured by: Alkem Laboratories Ltd., Mumbai - 400 013 India, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054, NDC 67877-438-30.
by Ascend Laboratories LLC
- Reason
- Failed Dissolution Specifications: low out of specification results for dissolution testing.
- Published
- February 12, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Ranitidine Hydrochloride (powder), USP, Rx only, Spectrum Chemical Mfg Corp., a) 1 gram, b) 5 grams, c) 25 grams, d)100 grams, e) 500 grams, f) 1 Kilogram
by Spectrum Laboratory Products
- Reason
- CGMP Deviations: Presence of NDMA impurity detected in product.
- Published
- February 12, 2020
- Distribution
- The recalled API was distributed to phar…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Almark Foods, LLC
- Product
- White Medium Hard Cooked Eggs sold under the brand names of:…
- Reason
- The firm was notified by FDA & CDC of a potential Listeria monocytogenes genetic match between environmental samples from our facility and case patient samples associated with an illness outbreak.
- Published
- February 12, 2020
- Distribution
- Product was shipped to the following sta…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Almark Foods, LLC
- Product
- Almark Foods Smokehouse ProBox Mini White Medium Hard Cooked…
- Reason
- The firm was notified by FDA & CDC of a potential Listeria monocytogenes genetic match between environmental samples from our facility and case patient samples associated with an illness outbreak.
- Published
- February 12, 2020
- Distribution
- Product was shipped to the following sta…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Almark Foods, LLC
- Product
- Almark Foods Smokehouse ProBox Cage Free Hard Cooked Eggs
- Reason
- The firm was notified by FDA & CDC of a potential Listeria monocytogenes genetic match between environmental samples from our facility and case patient samples associated with an illness outbreak.
- Published
- February 12, 2020
- Distribution
- Product was shipped to the following sta…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Almark Foods, LLC
- Product
- White Medium Hard Cooked Eggs w/Salt & Pepper sold under the…
- Reason
- The firm was notified by FDA & CDC of a potential Listeria monocytogenes genetic match between environmental samples from our facility and case patient samples associated with an illness outbreak.
- Published
- February 12, 2020
- Distribution
- Product was shipped to the following sta…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Almark Foods, LLC
- Product
- Vital Farms Pasture Raised Hard Cooked Eggs w/Salt & Pepper
- Reason
- The firm was notified by FDA & CDC of a potential Listeria monocytogenes genetic match between environmental samples from our facility and case patient samples associated with an illness outbreak.
- Published
- February 12, 2020
- Distribution
- Product was shipped to the following sta…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Almark Foods, LLC
- Product
- Eggland's Best Cage Free Hard Cooked Eggs w/Salt & Pepper
- Reason
- The firm was notified by FDA & CDC of a potential Listeria monocytogenes genetic match between environmental samples from our facility and case patient samples associated with an illness outbreak.
- Published
- February 12, 2020
- Distribution
- Product was shipped to the following sta…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Almark Foods, LLC
- Product
- Almark Foods Cage Free Hard Cooked Eggs w/Salt & Pepper
- Reason
- The firm was notified by FDA & CDC of a potential Listeria monocytogenes genetic match between environmental samples from our facility and case patient samples associated with an illness outbreak.
- Published
- February 12, 2020
- Distribution
- Product was shipped to the following sta…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Almark Foods, LLC
- Product
- PECKISH PERFECTLY BOILED FREE RANGE ORGANIC Egg Salt & Pepit…
- Reason
- The firm was notified by FDA & CDC of a potential Listeria monocytogenes genetic match between environmental samples from our facility and case patient samples associated with an illness outbreak.
- Published
- February 12, 2020
- Distribution
- Product was shipped to the following sta…
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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