Drug and pharmaceutical recalls
17625 federal recalls on file. Federal recalls for prescription drugs, OTC medications, supplements, and pharmaceuticals. Sourced from the FDA and translated into plain English.
- 2017-08-02FDA-DrugSCA PharmaceuticalsClass IIfentaNYL as citrate 5 mcg/mL in 0.9% Sodium Chloride 1 mL in Single Dose syringe, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0225-24
Lack of Assurance of Sterility; product has the potential to leak.
- 2017-08-02FDA-DrugSCA PharmaceuticalsClass IIfentaNYL (as citrate) 10 mcg per mL in 0.9% Sodium Chloride 250 mL Bag, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0202-40
Lack of Assurance of Sterility; product has the potential to leak.
- 2017-08-02FDA-DrugSCA PharmaceuticalsClass IIfentaNYL (as citrate) 5 mcg/mL In 250 mL 0.9% Sodium Chloride Injection Bag (Total fentaNYL Dose 1250 mcg/ 250 mL), Preservative Free, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0201-40
Lack of Assurance of Sterility; product has the potential to leak.
- 2017-08-02FDA-DrugSCA PharmaceuticalsClass IIBUPIVacaine HCl 0.2% IN 0.9% Sodium Chloride 250 mL Bag Preservative Free (Total Dose Bupivacaine 500 mg per 250 mL), Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0066-40
Lack of Assurance of Sterility; product has the potential to leak.
- 2017-08-02FDA-DrugSCA PharmaceuticalsClass IIBUPIVacaine HCl 0.125% In 250 mL 0.9% Sodium Chloride Bag, Preservative Free (Total Dose Bupivacaine 312.5 mg per 250 mL), Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0062-40
Lack of Assurance of Sterility; product has the potential to leak.
- 2017-08-02FDA-DrugSCA PharmaceuticalsClass IIBUPIVacaine HCl 0.1% PF (From 0.75%) in 0.9% Sodium Chloride, 250 mL Bag, Preservative Free (Waste From 250 mL Bag), Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0060-40
Lack of Assurance of Sterility; product has the potential to leak.
- 2017-08-02FDA-DrugSCA PharmaceuticalsClass IIPHENYLephrine HCl 10 mg in 0.9% Sodium Chloride, (Final Concentration = 0.1 mg per mL), Total Volume 100 mL Single Dose Container bag, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct, Little Rock, AR 72205 (877) 550-5059; NDC: 70004-0810-32.
Lack of Assurance of Sterility: Product made with recalled 0.9% sodium chloride bags which have the potential to leak.
- 2017-08-02FDA-DrugSCA PharmaceuticalsClass IIMAGNESIUM Sulfate 4 g added to 100 mL 0.9% Sodium Chloride, Total Approximate Volume 108 mL (does not include mfg. overfill) Single Dose Container bag, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct, Little Rock, AR 72205 (877) 550-5059; NDC: 70004-0737-32.
Lack of Assurance of Sterility: Product made with recalled 0.9% sodium chloride bags which have the potential to leak.
- 2017-08-02FDA-DrugSCA PharmaceuticalsClass IIDiltiazem 125 mg in 0.9% Sodium Chloride, 1 mg per mL, Total Volume 125 mL Single Dose Container bag, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct, Little Rock, AR 72205 (877) 550-5059; NDC: 70004-0541-35.
Lack of Assurance of Sterility: Product made with recalled 0.9% sodium chloride bags which have the potential to leak.
- 2017-08-02FDA-DrugSCA PharmaceuticalsClass IIceFAZolin 3 g added to 100 mL 0.9% Sodium Chloride, Total Approximate Volume 115 mL Single Dose Container bag, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct, Little Rock, AR 72205 (877) 550-5059; NDC: 70004-0524-32.
Lack of Assurance of Sterility: Product made with recalled 0.9% sodium chloride bags which have the potential to leak.
- 2017-08-02FDA-DrugSCA PharmaceuticalsClass IIfentaNYL (as citrate) 10 mcg per mL in 0.9% Sodium Chloride, (Total fentaNYL Dose 1,000 mcg/100 mL), Total Volume 100 mL Single Dose Container bag, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct, Little Rock, AR 72205 (877) 550-5059; NDC: 70004-0202-32.
Lack of Assurance of Sterility: Product made with recalled 0.9% sodium chloride bags which have the potential to leak.
- 2017-08-02FDA-DrugSCA PharmaceuticalsClass IImorphine sulfate 1 mg per mL in 0.9% Sodium Chloride, (Total morphine Dose 100 mg/100 mL), Total Volume 100 mL Single Dose Container bag, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct, Little Rock, AR 72205, (877) 550-5059; labeled as a) NDC: 70004-0100-59; b) NDC: 70004-100-58.
Lack of Assurance of Sterility: Product made with recalled 0.9% sodium chloride bags which have the potential to leak.
- 2017-07-26FDA-DrugValeant Pharmaceuticals North America LLCClass IIIObagi-C Rx System C-Therapy Night Cream, Net wt. 2 oz. (57g) bottle, Rx only, Distributed by OMP, Inc., Long Beach, CA Made in USA, NDC 62032-222-02
Labeling: Incorrect or Missing Package Insert - Obagi-C Rx System C-Therapy Night Cream is being recalled due to incomplete packaging/labeling. The bottle is missing the product insert and outer carton which contain the complete instruction for use and safety information.
- 2017-07-26FDA-DrugPharMedium Services, LlcClass IIPotassium PHOSphate in 5% Dextrose Injection, 15 mMol in 250 mL in 250 mL Intravia Bag Service, Rx Only. PharMEDium Services, LLC 12620 W. Airport Blvd #130 Sugar Land, TX 77478 800-523-7749 Service Code 2K5300 NDC# 61553-300-11
Lack of Assurance of Sterility; media fill failure at manufacturer
- 2017-07-26FDA-DrugPharMedium Services, LlcClass IIPotassium PHOSphate in 0.9% Sodium Chloride Injection, 30 mMol in a) 250 mL in 250 mL Intravia Bag Service Code 2K5290 NDC# 61553-290-11, b) 500 mL in 500 mL Intravia Bag Service Code 2K5285 NDC# 61553-285-03, Rx Only, PharMEDium Services, LLC 12620 W. Airport Blvd #130 Sugar Land, TX 77478 800-523-7749
Lack of Assurance of Sterility; media fill failure at manufacturer
- 2017-07-26FDA-DrugPharMedium Services, LlcClass IIPotassium PHOSphate in 5% Dextrose Injection, 9 mMol in 50 mL in 50 mL Intravia Bag, Rx Only, PharMEDium Services, LLC 12620 W. Airport Blvd #130 Sugar Land, TX 77478 800-523-7749 Service Code 2K5310 NDC# 61553-310-41
Lack of Assurance of Sterility; media fill failure at manufacturer
- 2017-07-26FDA-DrugPharMedium Services, LlcClass IIPotassium PHOSphate in 0.9% Sodium Chloride Injection, 9 mMol in 100 mL in 150 mL Intravia Bag, Rx Only, PharMEDium Services, LLC 12620 W. Airport Blvd #130 Sugar Land, TX 77478 800-523-7749 Service Code 2K5286 NDC# 61553-286-48
Lack of Assurance of Sterility; media fill failure at manufacturer
- 2017-07-26FDA-DrugPharMedium Services, LlcClass IIPotassium PHOSphate in 5% Dextrose Injection, 7.5 mMol in 100 mL in 150 mL Intravia Bag, Rx Only, PharMEDium Services, LLC 12620 W. Airport Blvd #130 Sugar Land, TX 77478 800-523-7749 Service Code 2K5299 NDC# 61553-299-48
Lack of Assurance of Sterility; media fill failure at manufacturer
- 2017-07-26FDA-DrugPharMedium Services, LlcClass IIPotassium PHOSphate in 0.9% Sodium Chloride Injection, 7.5 mMol in 100 mL in 150 mL Intravia Bag, Rx Only, PharMEDium Services, LLC 12620 W. Airport Blvd #130 Sugar Land, TX 77478 800-523-7749 Service Code 2K5298 NDC# 61553-298-48NDC# 61553-298-48
Lack of Assurance of Sterility; media fill failure at manufacturer
- 2017-07-26FDA-DrugPharMedium Services, LlcClass IIPotassium PHOSphate in 0.9% Sodium Chloride Injection, 7 mMol in 100 mL in 150 mL Intravia Bag, Rx Only, PharMEDium Services, LLC 12620 W. Airport Blvd #130 Sugar Land, TX 77478 800-523-7749 Service Code 2K5284 NDC# 61553-284-48
Lack of Assurance of Sterility; media fill failure at manufacturer
- 2017-07-26FDA-DrugPharMedium Services, LlcClass IIPotassium PHOSphate in 0.9% Sodium Chloride Injection, 40 mMol in 250 mL in 250 mL Intravia Bag, Rx Only, PharMEDium Services, LLC 12620 W. Airport Blvd #130 Sugar Land, TX 77478 800-523-7749 Service Code 2K5301 NDC# 61553-301-11
Lack of Assurance of Sterility; media fill failure at manufacturer
- 2017-07-26FDA-DrugPharMedium Services, LlcClass IIPotassium PHOSphate in 5% Dextrose Injection, 30 mMol 500 mL in 500 mL Intravia Bag, Rx Only, PharMEDium Services, LLC 12620 W. Airport Blvd #130 Sugar Land, TX 77478 800-523-7749 Service Code 2K5283 NDC# 61553-283-03
Lack of Assurance of Sterility; media fill failure at manufacturer
- 2017-07-26FDA-DrugPharMedium Services, LlcClass IIPotassium PHOSphate in 0.9% Sodium Chloride Injection 20 mMol in 100 mL in 150 mL Intravia Bag, Rx Only, PharMEDium Services, LLC 12620 W. Airport Blvd #130 Sugar Land, TX 77478 800-523-7749 Service Code 2K5287 NDC# 61553-287-48
Lack of Assurance of Sterility; media fill failure at manufacturer
- 2017-07-26FDA-DrugPharMedium Services, LlcClass IIPotassium PHOSphate in 0.9% Sodium Chloride Injection 15 mMol in a) 100 mL in 150 mL Intravia Bag Service Code 2K5295 NDC# 61553-295-48; b) 150 mL in 150 mL Intravia Bag Service Code 2K5292 NDC# 61553-292-01; c) 250 mL in 250 mL Intravia Bag Service Code 2K5282 NDC# 61553-282-11; d) 250 mL in 250 mL Intravia Bag with Additive Cap Service Code 2K5291 NDC# 61553-291-11, Rx Only PharMEDium Services, LLC 12620 W. Airport Blvd #130 Sugar Land, TX 77478 800-523-7749
Lack of Assurance of Sterility; media fill failure at manufacturer
- 2017-07-26FDA-DrugPharMedium Services, LlcClass IIPotassium PHOSphate in 0.9% Sodium Chloride Injection, 10 mMol in a) 100 mL in 150 mL Intravia Bag (NDC 61553-288-48) Service Code: 2K5288, and b) 250 mL in 250 mL Intravia Bag (NDC 61553-281-11) Service Code: 2K5281, Rx Only, PharMEDium Services, LLC 12620 W. Airport Blvd #130 Sugar Land, TX 77478 800-523-7749
Lack of Assurance of Sterility; media fill failure at manufacturer
- 2017-07-26FDA-DrugPharMedium Services, LlcClass IISuccinylcholine Chloride Injection (Preserved) 20 mg per mL, 200 mg per 10 mL, 10 mL Total Volume in BD Syringe, For IV Use, PharMedium Services, LLC, Cleveland, MS --- NDC 61553-364-65
Lack of Assurance of Sterility; media fill failure at manufacturer
- 2017-07-26FDA-DrugTeva Pharmaceuticals USAClass IIIBuprenorphine and Naloxone Sublingual Tablets 8 mg/2 mg 30 tablets per Bottle, Rx only, Distributed By: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0093-5721-56
Failed Impurities/Degradation Specifications: out of specification test results for related compounds largest unknown impurity.
- 2017-07-26FDA-DrugTeva Pharmaceuticals USAClass IIIBuprenorphine and Naloxone Sublingual Tablets, 2 mg/0.5 mg 30 tablets per bottle, Rx only, Distributed by: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0093-5720-56
Failed Impurities/Degradation Specifications: out of specification test results for related compounds largest unknown impurity.
- 2017-07-26FDA-DrugShionogi Inc.Class IIIPONSTEL (Mefanamic Acid) USP, 250 mg capsules, 30-count bottles, Rx Only, Manufactured for: Shionogi Inc. Florham Park, NJ 07932 Manufactured by: Halo Pharmaceutical Inc. Whippany, NJ 07981
Failed Dissolution Specifications: Low dissolution results were obtained during stability testing
- 2017-07-26FDA-DrugShionogi Inc.Class IIIMefenamic Acid, 250mg capsules, packaged in 30-count bottles, Rx Only, Distributed by: Prasco Laboratories Mason, OH 45040 USA, Manufactured by: Halo Pharmaceutical Inc. Whippany, NJ 07981, NDC 66993-070-30
Failed Dissolution Specifications: Low dissolution results were obtained during stability testing
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