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Drugs Recalls

Prescription and over-the-counter medications

17,302 Total Recalls

fentaNYL 2500 mcg/50 mL (50 mcg/mL) 50 mL bag, Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1436-76

QuVa Pharma

Class I - Dangerous

Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules

Nov 12, 2019 Prescription Drugs Nationwide View Details →

fentaNYL 200 mcg/100 mL (2 mcg/mL) ROPivacaine HCl 0.2% 200 mg/100 mL (2 mg/mL) in 0.9% Sodium Chloride 100 mL CADD, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478NDC 70092-1259-75

QuVa Pharma

Class I - Dangerous

Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules

Nov 12, 2019 Prescription Drugs Nationwide View Details →

fentaNYL 1250 mcg/250 mL (5 mcg/mL) in 0.9% Sodium Chloride 250 mL Bag Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1444-05

QuVa Pharma

Class I - Dangerous

Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules

Nov 12, 2019 Prescription Drugs Nationwide View Details →

EXPAREL, Bupivicaine Liposome Injectable Suspension, 1.3%, 266 mg/20 mL (13 mg/mL), Sterile, 20 mL vial, Rx only, Manufactured by: Pacira Pharmaceuticals, Inc. San Diego, CA 92121. NDC: 65250-266-20,

Pacira Pharmaceuticals

Class I - Dangerous

Sub Potent Drug: Out of Specification (OOS)

Nov 21, 2019 Prescription Drugs Nationwide View Details →

Regular Strength Zantac 75 mg, Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Chattanooga, TN 37409-0219. NDC 50269-222-25.

Sanofi-Aventis U.S.

Class I - Dangerous

CGMP Deviations: Presence of NDMA impurity detected in product.

Oct 22, 2019 Other Drugs Nationwide View Details →

fentaNYL 200 mcg/100 mL (2 mcg/mL) ROPivacaine HCl 0.2% 200 mg/100 mL (2 mg/mL) in 0.9% Sodium Chloride , 100 mL bag, Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1108-36

QuVa Pharma

Class I - Dangerous

Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules

Nov 12, 2019 Prescription Drugs Nationwide View Details →

fentaNYL 800 mcg/200 mL (4 mcg/mL) BUPivacaine HCl 0.1667% 333.4 mg/200 mL (1.667 mg/mL) in 0.9% Sodium Chloride 200 mL in 250 mL CADD Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1436-76

QuVa Pharma

Class I - Dangerous

Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules

Nov 12, 2019 Prescription Drugs Nationwide View Details →

Fluphenazine Decanoate Injection USP 125mg/5mL, (5 mL Multiple Dose Vial), Rx only, For IM or SC Use, Mfd in India for: AuroMedics Pharma, LLC, E. Windsor, NJ

AuroMedics Pharma

Class I - Dangerous

Discoloration; Hazy solution found in one vial instead of a clear solution.

Nov 12, 2019 Prescription Drugs View Details →

Regular Strength Zantac 75 mg, Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Chattanooga, TN 37409-0219. NDC's 67751-152-01 67751-152-02

Sanofi-Aventis U.S.

Class I - Dangerous

CGMP Deviations: Presence of NDMA impurity detected in product.

Oct 22, 2019 Other Drugs Nationwide View Details →

fentaNYL 550 mcg/55 mL (10 mcg/mL) in 0.9% Sodium Chloride 55 mL Syringe Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1274-50

QuVa Pharma

Class I - Dangerous

Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules

Nov 12, 2019 Prescription Drugs Nationwide View Details →

fentaNYL 400 mcg/200 mL (2 mcg/mL) ROPivacaine HCl 0.1% 200 mg/200 mL (1 mg/mL) in 0.9% Sodium Chloride 200 mL CADD, Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1441-76

QuVa Pharma

Class I - Dangerous

Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules

Nov 12, 2019 Prescription Drugs Nationwide View Details →

Zantac 150 mg, Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Chattanooga, TN 37409-0219. NDC's 66715-9736-2 66715-9736-3 66715-9736-8

Sanofi-Aventis U.S.

Class I - Dangerous

CGMP Deviations: Presence of NDMA impurity detected in product.

Oct 22, 2019 Other Drugs Nationwide View Details →

LETS GEL KIT Convenience Pack (To prepare 100 mL LETS GEL), Contains: LETS Powders for Gel: Lidocaine Hydrochloride - 4 g, Ephinephrine Bitartrate - 180 mg, Tetracaine Hydrochloride - 500 mg, Sodium Metabisulfite - 75 mg, SuturaGel Methlcellulose Base; RX Only, For Prescription Compounding, Fagron, Inc., 2400 Pilot Knob Rd, St. Paul, MN 55120. NDC: 51552-1539-1

Fagron

Class I - Dangerous

Microbial contamination of non-sterile product.

Oct 31, 2019 Prescription Drugs Nationwide View Details →

fentaNYL 200 mcg/100 mL (2 mcg/mL) BUPivacaine HCl 0.1% 100 mg/100 mL (1 mg/mL) in 0.9% Sodium Chloride Preservative Free 100 mL in 150 mL Bag, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1103-36

QuVa Pharma

Class I - Dangerous

Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules

Nov 12, 2019 Prescription Drugs Nationwide View Details →

Regular Strength Zantac 75 mg, Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Chattanooga, TN 37409-0219 NDC's 41167-0300-0, 41167-0300-1, 41167-0300-3, 41167-0300-5, 41167-0300-6, 41167-0300-7, 41167-0300-8

Sanofi-Aventis U.S.

Class I - Dangerous

CGMP Deviations: Presence of NDMA impurity detected in product.

Oct 22, 2019 Other Drugs Nationwide View Details →

fentaNYL 400 mcg/200 mL (2 mcg/mL) 0.1% ROPivacaine HCl 200 mg/200 mL (1 mg/mL) in 0.9% Sodium Chloride , 200 mL bag, Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1207-37

QuVa Pharma

Class I - Dangerous

Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules

Nov 12, 2019 Prescription Drugs Nationwide View Details →

Maximum Strength Zantac 150 mg Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Chattanooga, TN 37409-0219. NDC's 41167-0310-1 41167-0310-2 41167-0310-3 41167-0310-4 41167-0310-6 41167-0310-7 41167-0310-8

Sanofi-Aventis U.S.

Class I - Dangerous

CGMP Deviations: Presence of NDMA impurity detected in product.

Oct 22, 2019 Other Drugs Nationwide View Details →

fentaNYL 500 mcg/250 mL (2 mcg/mL) 0.125% BUPivacaine HCl 312.5 mg/250 mL (1.25 mg/mL) in 0.9% Sodium Chloride 250 mL Bag, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1105-37

QuVa Pharma

Class I - Dangerous

Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules

Nov 12, 2019 Prescription Drugs Nationwide View Details →

fentaNYL 1000 mcg/100 mL (10 mcg/mL) in 0.9% Sodium Chloride Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1092-36

QuVa Pharma

Class I - Dangerous

Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules

Nov 12, 2019 Prescription Drugs Nationwide View Details →

fentaNYL 200 mcg/100 mL (2 mcg/mL) BUPivacaine HCl 0.125% 125 mg/100 mL (1.25 mg/mL) in 0.9% Sodium Chloride Preservative Free, 100 mL in 150 Bag, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1104-36

QuVa Pharma

Class I - Dangerous

Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules

Nov 12, 2019 Prescription Drugs Nationwide View Details →