Drug and pharmaceutical recalls

17728 federal recalls on file. Federal recalls for prescription drugs, OTC medications, supplements, and pharmaceuticals. Sourced from the FDA and translated into plain English.

2018-11-21FDA-DrugSandoz IncClass III
Nitrofurantoin Capsules, USP (Monohydrate/Macrocrystals) 100 mg, 100-count bottoles, Rx Only, Manufactured for: Northstar Rx LLC Memphis, TN 38141 Manufactured by: Sandoz Inc. Princeton, NJ 08540,NDC 16714-439-01
Cross Contamination with Other Products
2018-11-21FDA-DrugSandoz IncClass II
Isosorbide Dinitrate Tablets, USP 20 mg,100-count bottles, Rx Only Manufactured by: Sandoz Inc., Princeton, NJ 08540 For BluePoint Laboratories, NDC 68001-222-00
Cross Contamination with Other Products
2018-11-21FDA-DrugSandoz IncClass II
Isosorbide Dinitrate Tablets, USP 10 mg,100-count bottles, Rx Only Manufactured by: Sandoz Inc., Princeton, NJ 08540 For BluePoint Laboratories, NDC 68001-225-00
Cross Contamination with Other Products
2018-11-21FDA-DrugSandoz IncClass II
Isosorbide Dinitrate Tablets, USP 5 mg,100-count bottles, Rx Only Manufactured by: Sandoz Inc., Princeton, NJ 08540 For BluePoint Laboratories, NDC 68001-223-00
Cross Contamination with Other Products
2018-11-21FDA-DrugSandoz IncClass II
Isosorbide Dinitrate Tablets, USP 20 mg, 100-count bottles, Rx Only, Distributed by: Sandoz Inc. Princeton, NJ 08540; NDC 0781-1695-01
Cross Contamination with Other Products
2018-11-21FDA-DrugSandoz IncClass III
Nitrofurantoin Capsules, USP (Monohydrate/Macrocrystals) 100 mg, packaged in a) 100-capsule bottles (NDC 0185-0122-01); and b) 1000-capsule bottles, (NDC 0185-0122-10); Rx Only, Distributed by Sandoz Inc. Princeton, NJ 08540
Cross Contamination with Other Products
2018-11-21FDA-DrugKadesh InternationalClass I
puriton EYE RELIEF DROPS, 0.5 oz (15 ml) bottle, Kadesh Inc., NDC#7079600115, UPC 7 36972 16799 0.
Non-Sterility: Product manufactured under non-sterile production conditions.
2018-11-21FDA-DrugEli Lilly & CoClass III
ERBITUX CETUXIMAB Injection, 200 mg/100 mL (2 mg/mL), 100 mL per single-use vial, Rx only, Manufactured by: ImClone LLC, a wholly-owned subsidiary of Eli Lilly and Company, Branchburg, NJ 08876 USA. NDC: 66733-958-23
Labeling: Missing label; potential for missing primary container label on the vial.
2018-11-21FDA-DrugZero Xtreme USAClass II
Zero Xtreme Dietary Supplement 30-count capsules. By:Zero Xtreme Registro Sanitario No SD2014-0002208 LLC-USA
Marketed Without an Approved NDA/ANDA: Undeclared Sibutramine
2018-11-21FDA-DrugRemedyRepack Inc.Class III
Metoprolol Tartrate Injection, USP 5mg/5mL, vials, Rx only, MFG: Claris Lifesciences Inc., North Brunswick, NJ 08902, NDC# 70518-0868-00
Failed pH Specifications: High Out-of-Specification results for pH were obtained during stability testing.
2018-11-21FDA-DrugTeva Pharmaceuticals USAClass II
Alprostadil Injection USP 500 micrograms/mL 1 mL single use vial, 5 vials per carton, Rx only, TEVA Pharmaceuticals USA, Inc., North Wales, PA --- NDC 0703-1501-02
Failed Impurities/Degradation Specifications; out-of-specification results for impurities obtained during routine stability testing
2018-11-21FDA-DrugRight Value Drug Stores, Inc.Class III
Tadalafil SR 12 mg Capsules packed in 8,13, 20, 30, 40 or 60 dram screw top pill bottle, Carie Boyd's Prescription Shop 122 Grapevine Hwy. Hurst, TX 76054 817-282-9376 NDC 99999-9969-51
Labeling Not Elsewhere Classified: Misbranding.
2018-11-21FDA-DrugRight Value Drug Stores, Inc.Class III
Tadalafil SR 7 mg Capsules packed in 8,13, 20, 30, 40 or 60 dram screw top pill bottle, Carie Boyd's Prescription Shop 122 Grapevine Hwy. Hurst, TX 76054. NDC 99999-9970-88
Labeling Not Elsewhere Classified: Misbranding.
2018-11-21FDA-DrugRight Value Drug Stores, Inc.Class III
Progesterone SR 200 mg Capsules, packed in 8,13, 20, 30, 40 or 60 dram screw top pill bottle, Carie Boyd's Prescription Shop 122 Grapevine Hwy. Hurst, TX 76054 817-282-9376. NDC 99999-0018-74
Labeling Not Elsewhere Classified: Misbranding.
2018-11-21FDA-DrugRight Value Drug Stores, Inc.Class III
Progesterone SR 100 mg Capsules, packed in 8,13, 20, 30, 40 or 60 dram screw top pill bottle, Carie Boyd's Prescription Shop 122 Grapevine Hwy. Hurst, TX 76054 817-282-9376. NDC 99999-0104-55
Labeling Not Elsewhere Classified: Misbranding.
2018-11-14FDA-DrugSilver Star BrandsClass II
Healthful Naturals Leg Cramp Support Oral Spray, 2 fl oz (59 mL) per bottle, Distributed by: Silver Star Brands, Oshkosh, WI 54906 NDC 68703-206-02
CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
2018-11-14FDA-DrugSilver Star BrandsClass II
Healthful Naturals DizziFree Oral Spray, 2 fl oz (59 mL) per bottle, Distributed by: Silver Star Brands, Oshkosh, WI 54906. NDC 68703-204-02
CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
2018-11-14FDA-DrugSilver Star BrandsClass I
Native Remedies EyeClear Pro Oral Spray, 2 fl oz (59 mL) per bottle, Distributed by: Silver Star Brands, Oshkosh, WI 54906. NDC 68703-151-59
Microbial Contamination of Non-Sterile Product
2018-11-14FDA-DrugSilver Star BrandsClass I
Native Remedies VaricoGo Oral Spray, 2 fl oz (59 mL) per bottle, Distributed by: Silver Star Brands, Oshkosh, WI 54906. NDC 68703-105-59
Microbial Contamination of Non-Sterile Products
2018-11-14FDA-DrugSilver Star BrandsClass I
Native Remedies HypoSlim Oral Spray, 2 fl oz (59 mL) per bottle, Distributed by: Silver Star Brands, Oshkosh, WI 54906. NDC 68703-275-02
Microbial Contamination of Non-Sterile Products
2018-11-14FDA-DrugSilver Star BrandsClass I
Native Remedies VertiFree Oral Spray, 2 fl oz (59 mL) per bottle, Distributed by: Silver Star Brands, Oshkosh, WI 54906. NDC 68703-253-02
Microbial Contamination of Non-Sterile Products
2018-11-14FDA-DrugMedline Industries IncClass II
SparkleFresh Fluoride Toothpaste, Sodium Monofluorophosphate 0.76%, a) 17 g tube (NDC 53329-083-92, product number NONTP6I), b) 24 g tube (NDC 53329-083-93, product number NONTP85I), c) 42.5 g (NDC 53329-083-21, product number NONTP15I), d) 24 g tube (NDC 53329-081-93, product number DGN1000), Made in Malaysia for Medline Industries, Inc., Three Lakes Drive, Northfield, IL 60093 USA
Microbial Contamination of Non-Sterile Product
2018-11-14FDA-DrugQualgen, LLCClass II
Testosterone 200 mg/Anastrozole 20 mg pellet, 1 count (NDC 69761-222-01), 6 count (NDC 69761-222-06), 12 count (NDC 69761-222-12), and 30 count (NDC 69761-222-30) vials, Rx Only, Qualgen, Edmond, OK 73013
Lack of Assurance of Sterility
2018-11-14FDA-DrugQualgen, LLCClass II
Testosterone 87.5mg pellet, 1 count (NDC 69761-187-01), 6 count (NDC 69761-187-06), 12 count (NDC 69761-187-12), and 30 count (NDC 69761-187-30) vials, Rx Only Qualgen, LLC, Edmond, OK 73013
Lack of Assurance of Sterility
2018-11-14FDA-DrugQualgen, LLCClass II
Testosterone 50mg pellet, 1 count (NDC 69761-150-01), 6 count (NDC 69761-150-06), 12 count (NDC 69761-150-12), and 30 count (NDC 69761-150-30) vials, Rx Only Qualgen, LLC, Edmond, OK 73013
Lack of Assurance of Sterility
2018-11-14FDA-DrugQualgen, LLCClass II
Testosterone 37.5 mg pellet, 1 count (NDC 69761-137-01), 6 count (NDC 69761-137-06), 12 count (NDC 69761-137-12) and 30 count (NDC 69761-137-30) vials, Rx Only, Qualgen, LLC, Edmond, OK 73013
Lack of Assurance of Sterility
2018-11-14FDA-DrugQualgen, LLCClass II
Testosterone 25 mg pellet, 1 count (NDC: 69761-125-01) and 30 count vials (NDC: 69761-125-30), Rx Only Qualgen, LLC, Edmond, OK 73013
Lack of Assurance of Sterility
2018-11-14FDA-DrugQualgen, LLCClass II
Testosterone 200mg pellet, 1 count (NDC 69761-120-01), 6 count (NDC 69761-120-06), 12 count (NDC 69761-120-12), and 30 count (NDC 69761-120-30) vials, Rx Only Qualgen, LLC, Edmond, OK 73013
Lack of Assurance of Sterility
2018-11-14FDA-DrugQualgen, LLCClass II
Testosterone 12.5mg pellet, 1 count (NDC 69761-112-01), 6 count (NDC 69761-112-06), 12 count (NDC 69761-112-12), and 30 count (NDC 69761-112-30) vials, Rx Only Qualgen, LLC, Edmond, OK 73013
Lack of Assurance of Sterility
2018-11-14FDA-DrugQualgen, LLCClass II
Testosterone 100mg pellet, 1 count (NDC 69761-110-01), 6 count (NDC 69761-110-06), 12 count (NDC 69761-110-12), and 30 count (NDC 69761-110-30) vials, Rx Only Qualgen, LLC, Edmond, OK 73013
Lack of Assurance of Sterility

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