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Drugs Recalls

Prescription and over-the-counter medications

17,302 Total Recalls

Maximum Strength Zantac 150 mg, Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Chattanooga, TN 37409-0219. NDC's: 0597-0121-01, 0597-0121-06, 0597-0121-08, 0597-0121-09, 0597-0121-11, 0597-0121-24, 0597-0121-38, 0597-0121-50, 0597-0121-64, 0597-0121-66, 0597-0121-68, 0597-0121-78, 0597-0121-80, 0597-0121-82, 0597-0121-85, 0597-0121-90, 0597-0121-94.

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 1000 mcg/20 mL (50 mcg/mL) 20 mL in 20 mL Syringe Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1415-47

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 250 mcg/5 mL (50 mcg/mL), 5 mL Syringe, Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1098-44

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 2500 mcg/250 mL (10 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 70092-1093-37

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 →

Cool Mint Maximum Strength Zantac 150 mg, Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Chattanooga, TN 37409-0219 NDC's: 41167-0320-1 41167-0320-2 41167-0320-3 41167-0320-4 41167-0320-5 41167-0320-6 41167-0320-7

Sanofi-Aventis U.S.

Class I - Dangerous

CGMP Deviations: Presence of NDMA impurity detected in product.

Oct 22, 2019 Other 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 68151-2584-0.

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) BUPivacaine HCl 0.1% 100 mg/100 mL (1 mg/mL) in 0.9% Sodium Chloride 100 mL CADD Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1255-75

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 100 mcg/2 mL (50 mcg/mL) Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1097-43

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 100 mL CADD Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1250-75

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 1500 mcg/30 mL (50 mcg/mL) 30 mL in 35 mL Syringe Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1099-49

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 150 mg, Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Chattanooga, TN 37409-0219. NDC 67751-151-01.

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) ROPivacaine HCl 0.2% 500 mg/250 mL (2 mg/mL) in 0.9% Sodium Chloride 250 mL Bag Rx, Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1225-37

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 →

Zantac 75 mg, Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Chattanooga, TN 37409-0219. NDC's 0597-0122-01 0597-0122-08 0597-0122-13 0597-0122-37 0597-0122-40 0597-0122-54 0597-0122-61 0597-0122-81 0597-0122-96

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) ROPivacaine HCl 0.2% 400 mg/200 mL (2 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 70092-1440-76

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) 0.125% Bupivacaine HCl 125 mg/100 mL (1.25 mg/mL) in 0.9% Sodium Chloride, 100 mL CADD Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1202-75

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 500 mcg/250 mL (2 mcg/mL) Bupivacaine HCl 0.1% 250 mg/250 mL (1 mg/mL) in 0.9% Sodium Chloride 250 mL Bag, Rx only, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1160-37

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 1500 mcg/30 mL (50 mcg/mL) 30 mL PCA Vial Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1180-79

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 150 mg Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Chattanooga, TN 37409-0219. NDC 05269-220-25.

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 500 mcg/250 mL (2 mcg/mL) BUPivacaine HCl 0.0625% 156.25 mg/250 mL (0.625 mg/mL) in 0.9% Sodium Chloride in 250 mL Bag, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1269-37

QuVa Pharma

Class I - Dangerous

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

Nov 12, 2019 Other Drugs Nationwide View Details →

Potassium Phosphate, Monobasic, Crystal, NF, Multi-Compendial, Bulk Pharmaceutical Chemical, packaged in a) 500G glass bottles, product number 3248-01, NDC 10106-3248-1; b) 2.5KG glass bottles, product number 3248-05, NDC 10106-3248-2; c) 12KG pails, product number 3248-07, NDC 10106-3248-3; d) 1KT bottles and drums, product number 3248-X2; e) 1KT bottles and drums, product number 3248-X3; f) 12KG pails, product number 7390-19; Avantor Performance Materials, LLC, 100 Matsonford, Road, Suite 200, Radnor, PA 19087.

Avantor Performance Materials

Class I - Dangerous

Failed Stability Specifications: Product exceeds compendia and firm's specifications for iron content.

Oct 30, 2019 Other Drugs Nationwide View Details →