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.
- 2017-08-09FDA-DrugFusion IV Pharmaceuticals, Inc. dba Axia PharmaceuticalClass IITestosterone Cypionate + Progesterone, 200 mg/ 2.5 mg/mL ,10 mL amber glass vials, Rx Only, Compounded by AXIA Pharmaceutical, Los Angeles, CA 90025
CGMP Deviations
- 2017-08-09FDA-DrugTeva Pharmaceuticals USAClass IIIAlbuterol Sulfate Inhalation Solution, 0.021% (0.63 mg/3mL), packaged in 5 pouches of 5 x 3mL Sterile Unit-Dose Vials For Inhalation per carton, Rx only, Mfd. for: Watson Laboratories, Inc., Corona, CA 92880; Mfd. by: Cipla Ltd., Verna, Goa INDIA, NDC 0591-3467-53.
Failed Impurities/Degradation Specifications: high out of specification results for related compound D.
- 2017-08-09FDA-DrugDr. Reddy's Laboratories, Inc.Class IIIPravastatin Sodium Tablets, USP, 10 mg, packaged in a) 90-count bottles (NDC 55111-229-90) and b) 500-count bottles (NDC 55111-229-05), Rx only, Manufactured by: Dr. Reddy's Laboratories Limited, Bachupally - 500 090 INDIA; Distributed by: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540 USA.
Failed Impurities/Degradation Specifications: high out of specification results for related impurity for lot C700220.
- 2017-08-09FDA-DrugPrecision Dose Inc.Class IICarbamazepine Oral Suspension, USP. 100 mg/5 mL, 5 mL Unit Dose Cups, Rx Only, Pkg: Precision Dose, Inc., S. Beloit, IL 61080, NDC 68094-301-59.
Labeling Error: Label mix-up. Products' unit dose cups are correctly labeled, but the product carton lists incorrect volume and NDC.
- 2017-08-09FDA-DrugApace KY LLCClass IICyclobenzaprine HCl Tablets, USP, 5 mg, 50 Tablets (5x10) Unit Dose Cartons, Rx Only, Manufactured for: AvKARE Inc, Pulaski, TN 38478 --- NDC: 50268-0190-15
Labeling; Label Mix up; cartons labeled as Amantadine HCl 100 mg Capsules contain unit dose blister cards of Cyclobenzaprine HCl Tablet, USP 5 mg
- 2017-08-09FDA-DrugApace KY LLCClass IIAmantadine HCl Capsules, USP, 100 mg, Rx Only, 50 Capsules (5x10) Unit Dose Cartons, Manufactured for: AvKARE Inc, Pulaski, TN 38478 --- NDC: 50268-0069-15
Labeling; Label Mix up; cartons labeled as Amantadine HCl 100 mg Capsules contain unit dose blister cards of Cyclobenzaprine HCl Tablet, USP 5 mg
- 2017-08-02FDA-DrugSCA PharmaceuticalsClass IIfentaNYL 2 mcg/mL + Ropivacaine 0.2% PF in NS 250 mL, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0260-40
Lack of Assurance of Sterility; product has the potential to leak.
- 2017-08-02FDA-DrugSCA PharmaceuticalsClass IIPotassium Chloride 40 meq Added to Sodium Chloride 0.9% 250 mL, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 ---- NDC# 70004-0833-40
Lack of Assurance of Sterility; product has the potential to leak.
- 2017-08-02FDA-DrugSCA PharmaceuticalsClass IIPotassium Chloride 20 meq Added to Sodium Chloride 0.9% 250 mL, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0832-40
Lack of Assurance of Sterility; product has the potential to leak.
- 2017-08-02FDA-DrugSCA PharmaceuticalsClass IIPHENYLephrine 50 mg in 0.9% Sodium Chloride 250 mL, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0820-40
Lack of Assurance of Sterility; product has the potential to leak.
- 2017-08-02FDA-DrugSCA PharmaceuticalsClass IIPHENYLephrine 20 mg in 0.9% Sodium Chloride 250 mL Bag, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0816-40
Lack of Assurance of Sterility; product has the potential to leak.
- 2017-08-02FDA-DrugSCA PharmaceuticalsClass IIPHENYLephrine 200 mg in 0.9% Sodium Chloride 250 mL, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0815-40
Lack of Assurance of Sterility; product has the potential to leak.
- 2017-08-02FDA-DrugSCA PharmaceuticalsClass IIPHENYLephrine 100 mg in 0.9% Sodium Chloride 250 mL Bag, Rx only, SCA Pharmaceuticals 882PHENYLephrine 100 mg 1 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0813-40
Lack of Assurance of Sterility; product has the potential to leak.
- 2017-08-02FDA-DrugSCA PharmaceuticalsClass IIPHENYLephrine 40 mg in 0.9% Sodium Chloride 250 mL, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0812-40
Lack of Assurance of Sterility; product has the potential to leak.
- 2017-08-02FDA-DrugSCA PharmaceuticalsClass IIPHENYLephrine 10 mg in 0.9% Sodium Chloride 250 mL bag, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 ---- NDC# 70004-0811-59
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 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.
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