FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Ventura Foods, LLC
- Product
- Classic Gourmet Dressing; Country French; Net Wt 1.5 OZ.; Ve…
- Reason
- A plastic foreign object was inadvertently introduced into the product stream. The firm is recalling product as not all plastic has been accounted.
- Published
- January 24, 2018
- Distribution
- Nationwide
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FDA Recall
Terminated
Historical recordClass II
Docetaxel Injection USP, 20 mg/mL, One-Vial Formulation, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Visakhapatnam - 530 046 INDIA, NDC 43598-611-11
by Dr. Reddy's Laboratories, Inc.
- Reason
- Defective Container: Product complaints received of defect in the seal of the Docetaxel injection vials that the aluminum seal and/or stopper is removed when the cap is flipped off.
- Published
- January 17, 2018
- Distribution
- Nationwide
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FDA Recall
Terminated
Historical recordClass III
Gabapentin Oral Solution, 250 mg/5 mL (50 mg/mL) in a 470 mL amber-colored bottle, Rx Only. Manufactured by: Hi-Tech Pharmacal Co., Inc. Amityville, NY 11701. NDC: 50383-311-47
by Akorn Inc
- Reason
- CGMP Deviations: Inadvertent release of a drug product with unapproved active ingredient manufacturer.
- Published
- January 17, 2018
- Distribution
- Nationwide
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FDA Recall
Terminated
Historical recordClass II
Valsartan Tablets, USP, 160 mg, 90-count bottles, Rx Only, Manufactured by: Zhejiang Huahai Pharmaceutical Co., Ltd, Xunqiao, Linhai, Zhejiang 317024, China; Distributed by: Solco Healthcare US, LLC, Cranbury, NJ 08512, USA; NDC 43547-369-09.
by Prinston Pharmaceutical Inc
- Reason
- Failed Tablet/Capsule Specifications: confirmed customer complaint of thicker and heavier tablets in bottle.
- Published
- January 17, 2018
- Distribution
- Nationwide
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FDA Recall
Terminated
Historical recordClass II
Moexipril Hydrochloride and Hydrocholorothiazide Tablets USP, 7.5 mg/12.5 mg, 100-count bottle, Rx only, Distributed By: TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454, NDC 0093-5213-01.
by Teva Pharmaceuticals USA
- Reason
- Failed Impurities/Degradation Specifications: High out of specification test result for the Moexipril Diketopiperazine impurity was obtained during routine stability testing.
- Published
- January 17, 2018
- Distribution
- Nationwide
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FDA Recall
Terminated
Historical recordClass II
7-Keto DHEA 25mg Capsule, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
by KRS Global Biotechnology, Inc
- Reason
- Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.
- Published
- January 17, 2018
- Distribution
- Nationwide
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FDA Recall
Terminated
Historical recordClass II
7-Ketodehydroepiandrosterone (7-Keto DHEA) 100 mg Capsule, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
by KRS Global Biotechnology, Inc
- Reason
- Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.
- Published
- January 17, 2018
- Distribution
- Nationwide
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FDA Recall
Terminated
Historical recordClass II
Vitamin 10 B Lyophilized Vial, For IM Use, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
by KRS Global Biotechnology, Inc
- Reason
- Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.
- Published
- January 17, 2018
- Distribution
- Nationwide
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FDA Recall
Terminated
Historical recordClass II
Vitamin 9 A/B Lyophilized Vial, For IM Use, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
by KRS Global Biotechnology, Inc
- Reason
- Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.
- Published
- January 17, 2018
- Distribution
- Nationwide
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FDA Recall
Terminated
Historical recordClass II
Vitamin 9 Lyophilized Vial, For IM Use, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
by KRS Global Biotechnology, Inc
- Reason
- Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.
- Published
- January 17, 2018
- Distribution
- Nationwide
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FDA Recall
Terminated
Historical recordClass II
Cyclopentolate HCl/ Phenylephrine HCl/ Tropicamide/ Ketorolac 1%/ 10%/ 1%/ 0.5% Ophthalmic Soln, 5 mL Multi Dose Droptainer, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
by KRS Global Biotechnology, Inc
- Reason
- Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.
- Published
- January 17, 2018
- Distribution
- Nationwide
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FDA Recall
Terminated
Historical recordClass II
Cyclopentolate HCl/ Phenylephrine HCl/ Tropicamide/ Ketorolac 1%/ 2.5%/ 1%/ 0.5% Ophthalmic Solution, 3 mL Multi Dose Droptainer, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
by KRS Global Biotechnology, Inc
- Reason
- Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.
- Published
- January 17, 2018
- Distribution
- Nationwide
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FDA Recall
Terminated
Historical recordClass II
T-105 (Prostaglandin E1, 10 mcg/ Papaverine 30 mg/ Phentolamine 1 mg/mL), For Intracavernouse Use, 5 mL Vial, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
by KRS Global Biotechnology, Inc
- Reason
- Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.
- Published
- January 17, 2018
- Distribution
- Nationwide
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FDA Recall
Terminated
Historical recordClass II
Trimix #23F (Prostaglandin E1 6 mcg/ Papaverine HCl 17.8 mg/ Phentolamine Mesylate 0.6 mg/mL), For Intracavernous Use, 5 mL Vial, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
by KRS Global Biotechnology, Inc
- Reason
- Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.
- Published
- January 17, 2018
- Distribution
- Nationwide
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FDA Recall
Terminated
Historical recordClass II
Trimix #22F (Prostaglandin E1 25 mcg/ Papaverine HCl 30 mg/ Phentolamine Mesylate 2 mg/mL), For Intracavernous Use, 5 mL Vial, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
by KRS Global Biotechnology, Inc
- Reason
- Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.
- Published
- January 17, 2018
- Distribution
- Nationwide
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FDA Recall
Terminated
Historical recordClass II
Sincalide 5 mcg Lyophilized Vials, For IV Use, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
by KRS Global Biotechnology, Inc
- Reason
- Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.
- Published
- January 17, 2018
- Distribution
- Nationwide
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FDA Recall
Terminated
Historical recordClass II
Sermorelin Acetate 3 mg/ GHRP6 3 mg, Lyophilized Vial, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
by KRS Global Biotechnology, Inc
- Reason
- Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.
- Published
- January 17, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Sermorelin, 3 mg/ GHRP6, 3 mg/GHRP2, 3 mg, Vial - Lyophilized, For SC Use, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
by KRS Global Biotechnology, Inc
- Reason
- Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.
- Published
- January 17, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Sermorelin, 3 mg/ GHRP6, 1.8 mg/ GHRP2, 1.8 mg/mL in 3 mL Cartridge, For SC Use, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
by KRS Global Biotechnology, Inc
- Reason
- Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.
- Published
- January 17, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Sermorelin 500 mcg Orally Disintegrating Tablets (ODT), Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
by KRS Global Biotechnology, Inc
- Reason
- Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.
- Published
- January 17, 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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