Drug and pharmaceutical recalls
17730 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 IIPHENYLephrine HCl 10 mg in 0.9% Sodium Chloride 250 mL Bag, Preservative Free, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0811-40
Lack of Assurance of Sterility; product has the potential to leak.
- 2017-08-02FDA-DrugSCA PharmaceuticalsClass IIPHENYLephrine HCl 25 mg in 0.9% Sodium Chloride 250 mL, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0810-40
Lack of Assurance of Sterility; product has the potential to leak.
- 2017-08-02FDA-DrugSCA PharmaceuticalsClass IIPHENYLephrine HCl 60 mg in 0.9% Sodium Chloride 250 mL, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0809-40
Lack of Assurance of Sterility; product has the potential to leak.
- 2017-08-02FDA-DrugSCA PharmaceuticalsClass IINORepinephrine Bitartrate 16 mg in 0.9% Sodium Chloride 250 mL from Stock, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0775-40
Lack of Assurance of Sterility; product has the potential to leak.
- 2017-08-02FDA-DrugSCA PharmaceuticalsClass IINORepinephrine Bitartrate 8 mg in 0.9% Sodium Chloride 250 mL, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0774-40
Lack of Assurance of Sterility; product has the potential to leak.
- 2017-08-02FDA-DrugSCA PharmaceuticalsClass IINORepinephrine 4 mg in 0.9% Sodium Chloride 250 mL from Stock, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0771-40
Lack of Assurance of Sterility; product has the potential to leak.
- 2017-08-02FDA-DrugSCA PharmaceuticalsClass IIEPINEPHrine HCl 4 mg in 0.9% Sodium Chloride 250 mL, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0613-40
Lack of Assurance of Sterility; product has the potential to leak.
- 2017-08-02FDA-DrugSCA PharmaceuticalsClass IIePHEDrine Sulfate 5 mg/mL in NS 5 mL Fill in 12 mL Syringe (25 mg), Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0600-11
Lack of Assurance of Sterility; product has the potential to leak.
- 2017-08-02FDA-DrugSCA PharmaceuticalsClass IIHydromorphone 0.5 mg/mL in 0.9% Sodium Chloride 1 mL Fill in 3 mL BD syringe, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0302-05
Lack of Assurance of Sterility; product has the potential to leak.
- 2017-08-02FDA-DrugSCA PharmaceuticalsClass IIfentaNYL 3 mcg/mL + BUPIvacaine 0.1% in 0.9% Sodium Chloride 250 mL, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0290-40
Lack of Assurance of Sterility; product has the potential to leak.
- 2017-08-02FDA-DrugSCA PharmaceuticalsClass IIfentaNYL 2 mcg/mL + BUPIvacaine 0.125% PF in 0.9% Sodium Chloride 250 mL, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0254-40
Lack of Assurance of Sterility; product has the potential to leak.
- 2017-08-02FDA-DrugSCA PharmaceuticalsClass IIfentaNYL 2 mcg/mL + BUPIvacaine 0.1% PF in 0.9% NS 250 mL, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0230-40
Lack of Assurance of Sterility; product has the potential to leak.
- 2017-08-02FDA-DrugSCA PharmaceuticalsClass IIfentaNYL 10 mcg/mL PF in Sodium Chloride 250 mL (Total Dose=2500 mcg), Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0229-40
Lack of Assurance of Sterility; product has the potential to leak.
- 2017-08-02FDA-DrugSCA PharmaceuticalsClass IIfentaNYL 10 mcg/mL PF in NS 1 mL Fill in 3 mL syringe, Rx only, SCA Pharmaceuticals, 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0229-05
Lack of Assurance of Sterility; product has the potential to leak.
- 2017-08-02FDA-DrugSCA PharmaceuticalsClass IIfentaNYL 2 mcg/mL+Bupivacaine 0.0625% PF in 0.9% Sodium Chloride 250 mL, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 ---- NDC# 70004-0226-40
Lack of Assurance of Sterility; product has the potential to leak.
- 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
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