Hazard Type

Sterility Issue Recalls

10,814 product recalls involving sterility issue. Search official CPSC, FDA, and USDA datasets for every recall issued due to this hazard.

10,814Total Recalls
297Critical
67933.1MUnits Affected
All Recalls

Every Sterility Issue Recall

Sorted by most recent. Click any recall for full details and safety information.

10,814 recalls
High RiskFDA
Sca Pharmaceuticals
fentaNYL 2 mcg/mL + BUPIvacaine 0.125% PF in 0.9% Sodium Chloride 250 mL, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 722...
Drugs·0 affected·Jul 14, 2017
High RiskFDA
Sca Pharmaceuticals
fentaNYL 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-...
Drugs·0 affected·Jul 14, 2017
High RiskFDA
Sca Pharmaceuticals
PHENYLephrine 50 mg in 0.9% Sodium Chloride 250 mL, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0820-40
Drugs·0 affected·Jul 14, 2017
High RiskFDA
Sca Pharmaceuticals
fentaNYL 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# 700...
Drugs·0 affected·Jul 14, 2017
High RiskFDA
Sca Pharmaceuticals
Hydromorphone 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...
Drugs·0 affected·Jul 14, 2017
High RiskFDA
Sca Pharmaceuticals
MAGNESIUM Sulfate 4 g added to 100 mL 0.9% Sodium Chloride, Total Approximate Volume 108 mL (does not include mfg. overfill) Single Dose ...
Drugs·40 affected·Jul 14, 2017
High RiskFDA
Sca Pharmaceuticals
PHENYLephrine HCl 10 mg in 0.9% Sodium Chloride 250 mL Bag, Preservative Free, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, A...
Drugs·0 affected·Jul 14, 2017
High RiskFDA
Sca Pharmaceuticals
morphine 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,...
Drugs·220 affected·Jul 14, 2017
High RiskFDA
Cantrell Drug Company
Ephedrine Sulfate in 0.9% Sodium Chloride 5 mL, 25 mg/5 mL (5 mg/mL) Single-Dose Syringe, Rx Only, Cantrell Drug Company 7321 Cantrell Rd...
Drugs·25,529 affected·Jul 14, 2017
High RiskFDA
Sca Pharmaceuticals
ePHEDrine 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 ---...
Drugs·0 affected·Jul 14, 2017
High RiskFDA
Cantrell Drug Company
Sodium Bicarbonate 8.4% Injection Solution 50 mL, 50 mEq (1mEq/mL) Single-Dose Syringe, Rx Only, Cantrell Drug Company 7321 Cantrell Rd....
Injectable Drugs·40,081 affected·Jul 14, 2017
High RiskFDA
Sca Pharmaceuticals
fentaNYL 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...
Drugs·0 affected·Jul 14, 2017
High RiskFDA
Sca Pharmaceuticals
PHENYLephrine 10 mg in 0.9% Sodium Chloride 250 mL bag, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 ---- NDC# 70004...
Drugs·0 affected·Jul 14, 2017
High RiskFDA
Cantrell Drug Company
Succinylcholine Chloride Injection Solution 10 mL, 200 mg/10 mL (20 mg/mL) Single-Dose Syringe, Rx Only, Cantrell Drug Company 7321 Cantr...
Injectable Drugs·57,430 affected·Jul 14, 2017
High RiskFDA
Sca Pharmaceuticals
BUPIVacaine HCl 0.2% IN 0.9% Sodium Chloride 250 mL Bag Preservative Free (Total Dose Bupivacaine 500 mg per 250 mL), Rx only, SCA Pharma...
Drugs·0 affected·Jul 14, 2017
High RiskFDA
Sca Pharmaceuticals
NORepinephrine 4 mg in 0.9% Sodium Chloride 250 mL from Stock, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC#...
Drugs·0 affected·Jul 14, 2017
High RiskFDA
Cantrell Drug Company
Ephedrine Sulfate Injection Solution 1 mL, 50 mg/1 mL (50 mg/mL) Single-Dose Syringe, Rx Only, Cantrell Drug Company 7321 Cantrell Rd L...
Injectable Drugs·7,656 affected·Jul 14, 2017
High RiskFDA
Sca Pharmaceuticals
BUPIVacaine 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 Pharmac...
Drugs·0 affected·Jul 14, 2017
High RiskFDA
Cantrell Drug Company
Succinylcholine Chloride Injection Solution 5 mL, 100 mg/5 mL (20 mg/mL) Single-Dose Syringe, Rx Only, Cantrell Drug Company 7321 Cantrel...
Injectable Drugs·18,015 affected·Jul 14, 2017
High RiskFDA
Cantrell Drug Company
Norepinephrine Bitartrate 16 mg Added to 0.9% Sodium Chloride 250 mL (64 mcg per mL) Single-Dose Bag, Rx Only, Cantrell Drug Company 7321...
Drugs·1,718 affected·Jul 14, 2017
High RiskFDA
Sca Pharmaceuticals
Potassium Chloride 20 meq Added to Sodium Chloride 0.9% 250 mL, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC...
Drugs·0 affected·Jul 14, 2017
High RiskFDA
Cantrell Drug Company
Glycopyrrolate Injection Solution, 2 mL 0.4 mg/2 mL (0.2 mg/mL) Single-Dose Syringe, Rx Only, Cantrell Drug Company 7321 Cantrell Rd Litt...
Injectable Drugs·21,080 affected·Jul 14, 2017
High RiskFDA
Sca Pharmaceuticals
Potassium Chloride 40 meq Added to Sodium Chloride 0.9% 250 mL, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 ---- ND...
Drugs·0 affected·Jul 14, 2017
High RiskFDA
Cantrell Drug Company
Adenosine in 0.9% Sodium Chloride 30mL, 90 mg/30 mL (3 mg/mL) Single-Dose Syringe, Rx Only, Cantrell Drug Company 7321 Cantrell Rd. Littl...
Drugs·6,210 affected·Jul 14, 2017
High RiskFDA
Cantrell Drug Company
Norepinephrine Bitartrate 8 mg Added to 0.9% Sodium Chloride 250 mL (32 mcg per mL) Single-Dose Bag, Rx Only, Cantrell Drug Company 7321 ...
Drugs·8,928 affected·Jul 14, 2017
High RiskFDA
Sca Pharmaceuticals
fentaNYL 10 mcg/mL PF in Sodium Chloride 250 mL (Total Dose=2500 mcg), Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 ...
Drugs·0 affected·Jul 14, 2017
High RiskFDA
Sca Pharmaceuticals
NORepinephrine Bitartrate 8 mg in 0.9% Sodium Chloride 250 mL, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC#...
Drugs·0 affected·Jul 14, 2017
High RiskFDA
Sca Pharmaceuticals
NORepinephrine Bitartrate 16 mg in 0.9% Sodium Chloride 250 mL from Stock, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72...
Drugs·0 affected·Jul 14, 2017
High RiskFDA
Sca Pharmaceuticals
PHENYLephrine HCl 25 mg in 0.9% Sodium Chloride 250 mL, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004...
Drugs·0 affected·Jul 14, 2017
High RiskFDA
Sca Pharmaceuticals
PHENYLephrine 100 mg in 0.9% Sodium Chloride 250 mL Bag, Rx only, SCA Pharmaceuticals 882PHENYLephrine 100 mg 1 Knoedl Ct Little Rock, AR...
Drugs·0 affected·Jul 14, 2017
High RiskFDA
Sca Pharmaceuticals
fentaNYL 3 mcg/mL + BUPIvacaine 0.1% in 0.9% Sodium Chloride 250 mL, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --...
Drugs·0 affected·Jul 14, 2017
High RiskFDA
Sca Pharmaceuticals
EPINEPHrine HCl 4 mg in 0.9% Sodium Chloride 250 mL, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0...
Drugs·0 affected·Jul 14, 2017
High RiskFDA
Sca Pharmaceuticals
PHENYLephrine HCl 10 mg in 0.9% Sodium Chloride, (Final Concentration = 0.1 mg per mL), Total Volume 100 mL Single Dose Container bag, Rx...
Drugs·2 affected·Jul 14, 2017
High RiskFDA
Cantrell Drug Company
Diltiazem HCl 125 mg in 5% Dextrose 125 mL Single-Dose- Bag, Rx Only, Cantrell Drug Company 7321 Cantrell Rd. Little Rock, AR 72207 877-...
Drugs·2,761 affected·Jul 14, 2017
High RiskFDA
Cantrell Drug Company
Norepinephrine Bitartrate 4 mg Added to 0.9% Sodium Chloride 250 mL (16 mcg per mL) Single-Dose Bag, Rx Only, Cantrell Drug Company 7321...
Drugs·3,039 affected·Jul 14, 2017
High RiskFDA
Cantrell Drug Company
Ephedrine Sulfate in 0.9% Sodium Chloride 10 mL, 50 mg/10 mL (5 mg/mL) Single-Dose Syringe, Rx Only, Cantrell Drug Company 7321 Cantrell ...
Drugs·24,638 affected·Jul 14, 2017
High RiskFDA
Baxter Healthcare Corporation
0.9% Sodium Chloride Injection USP, 250 mL VIAFLEX Container bag, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015; Distribut...
Injectable Drugs·131,904 affected·Jul 6, 2017
RecallFDA
Hospira Inc., A Pfizer Company
Argatroban Injection, 250 mg/2.5 mL (100 mg/mL), 5 mL Single-use vial, Rx Only, Sterile, Manufactured by: Gland Pharma Limited, Hyderabad...
Injectable Drugs·701 affected·Jul 6, 2017
High RiskFDA
Baxter Healthcare Corporation
5% Dextrose Injection, USP, 100 mL VIAFLEX Plastic Container, Rx only, Baxter Healthcare Corporation, Deerfield IL 60015 USA, Product Co...
Injectable Drugs·54,528 affected·Jul 6, 2017
High RiskFDA
Baxter Healthcare Corporation
0.9% Sodium Chloride Injection, USP, 100 mL VIAFLEX Container, Rx Only, Baxter Healthcare Corporation, Deerfield IL 60015 USA, Product C...
Injectable Drugs·295,200 affected·Jul 6, 2017
High RiskFDA
Cosman Medical, Llc
Nitinol TC Reusable Electrodes (TCN), Model Numbers: 1)TCN-10, 2) TCNK-10-R*, 3)TCN-10-3M, 4) TCNK-15, 5) TCN-15, 6) TCNK-15-C, 7) TCN-15...
Medical Devices·11,250 affected·Jul 5, 2017
High RiskFDA
Orthofix Srl
Orthofix Power Drill Torque Limiter, Sterile, Rx Only, Single Use; Sold individually and in the Galaxy UNYCO Diaphyseal Tibia Sterile Kit...
Medical Devices·416 affected·Jul 5, 2017
High RiskFDA
Sorin Group Usa, Inc.
SORIN GROUP, SMART PERFUSION PACK, SMART 1/4" PEDS PACK, REF 627262502, STERILE EO, Rx Only, 1 EA
Medical Devices·4 affected·Jun 29, 2017
High RiskFDA
Sorin Group Usa, Inc.
SORIN GROUP, SMART PERFUSION PACK, SMART CIRCULATORY ASSIST PACK, REF 627255003, STERILE EO, Rx Only, 1 EA
Medical Devices·98 affected·Jun 29, 2017
High RiskFDA
Sorin Group Usa, Inc.
NON-STERILE SAMPLE, SORIN GROUP, SMART PERFUSION PACK, REF 627376401, 1 EA, NOT FOR CLINICAL USE
Medical Devices·1 affected·Jun 29, 2017
High RiskFDA
Sorin Group Usa, Inc.
SORIN GROUP, SMART PERFUSION PACK, INSPIRE 8FS S5 PACK W/CARDIOPLEGIA-3D, (a) REF 044042600 AND (b) REF 044011200, STERILE EO, Rx Only, 1 EA
Medical Devices·733 affected·Jun 29, 2017
High RiskFDA
Sorin Group Usa, Inc.
SORIN GROUP, SMART PERFUSION PACK, INSPIRE 6FS, REF 044008204, STERILE EO, Rx Only, 1 EA
Medical Devices·52 affected·Jun 29, 2017
High RiskFDA
Sorin Group Usa, Inc.
SORIN GROUP, SMART PERFUSION PACK, SMA PRIMO2X OPTI PACK, REF 088512900, STERILE EO, Rx Only, 1 EA
Medical Devices·524 affected·Jun 29, 2017