FDA Recall
Terminated
Historical recordClass II
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
by QuVa Pharma, Inc.
- Reason
- Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
- Published
- December 11, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
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
by QuVa Pharma, Inc.
- Reason
- Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
- Published
- December 11, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
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
by QuVa Pharma, Inc.
- Reason
- Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
- Published
- December 11, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
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
by QuVa Pharma, Inc.
- Reason
- Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
- Published
- December 11, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
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
by QuVa Pharma, Inc.
- Reason
- Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
- Published
- December 11, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
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
by QuVa Pharma, Inc.
- Reason
- Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
- Published
- December 11, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
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
by QuVa Pharma, Inc.
- Reason
- Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
- Published
- December 11, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
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
by QuVa Pharma, Inc.
- Reason
- Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
- Published
- December 11, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
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
by QuVa Pharma, Inc.
- Reason
- Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
- Published
- December 11, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
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
by QuVa Pharma, Inc.
- Reason
- Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
- Published
- December 11, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
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
by QuVa Pharma, Inc.
- Reason
- Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
- Published
- December 11, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
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
by QuVa Pharma, Inc.
- Reason
- Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
- Published
- December 11, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
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
by QuVa Pharma, Inc.
- Reason
- Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
- Published
- December 11, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
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
by QuVa Pharma, Inc.
- Reason
- Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
- Published
- December 11, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
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
by QuVa Pharma, Inc.
- Reason
- Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
- Published
- December 11, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
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
by Sanofi-Aventis U.S. LLC
- Reason
- CGMP Deviations: Presence of NDMA impurity detected in product.
- Published
- December 11, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
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
by Sanofi-Aventis U.S. LLC
- Reason
- CGMP Deviations: Presence of NDMA impurity detected in product.
- Published
- December 11, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Regular Strength Zantac 75 mg, Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Chattanooga, TN 37409-0219. NDC 68151-2584-0.
by Sanofi-Aventis U.S. LLC
- Reason
- CGMP Deviations: Presence of NDMA impurity detected in product.
- Published
- December 11, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Regular Strength Zantac 150 mg, Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Chattanooga, TN 37409-0219. NDC 67751-151-01.
by Sanofi-Aventis U.S. LLC
- Reason
- CGMP Deviations: Presence of NDMA impurity detected in product.
- Published
- December 11, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
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.
by Sanofi-Aventis U.S. LLC
- Reason
- CGMP Deviations: Presence of NDMA impurity detected in product.
- Published
- December 11, 2019
- Distribution
- Nationwide
View recall →
Recall records are summarized from official FDA and USDA sources. Notices may be updated, reclassified, terminated, or withdrawn. Always review the linked official notice for the most current instructions.
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