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 →
FDA Recall
Ongoing
Historical recordClass II
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
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 05269-220-25.
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 41167-0310-1 41167-0310-2 41167-0310-3 41167-0310-4 41167-0310-6 41167-0310-7 41167-0310-8
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's 41167-0300-0, 41167-0300-1, 41167-0300-3, 41167-0300-5, 41167-0300-6, 41167-0300-7, 41167-0300-8
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
Terminated
Historical recordClass II
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
by Fagron, Inc
- Reason
- Microbial contamination of non-sterile product.
- Published
- December 11, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
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,
by Pacira Pharmaceuticals, Inc.
- Reason
- Sub Potent Drug: Out of Specification (OOS)
- Published
- December 11, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
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
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/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
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 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
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 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
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 0.1% 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
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 2000 mcg/100 mL (20 mcg/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 70092-1094-36
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 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
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 2750 mcg/55 mL (50 mcg/mL) 55 mL Syringe, Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1100-50
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) 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
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 →
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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