FDA Recall
Terminated
Historical recordClass III
Neomycin and Polymyxin B Sulfates and Dexamethasone Ophthalmic Suspension, Rx Only, Sterile, 5 mL bottle, Manufactured by Alcon Laboratories, Inc. Fort Worth, Texas 76134 for Sandoz Inc. Princeton, NJ 08540, NDC 61314-630-06
by Sandoz Inc
- Reason
- Labeling: Incorrect or missing package insert.
- Published
- November 6, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Bimatoprost Ophthalmic Solution 0.03%, Rx Only, For Topical Application to the Upper Eyelid, Sterile, a) 3 mL bottle NDC 0781-6206-93, b) 5 mL bottle NDC 0781-6206-75, Manufactured by Alcon Laboratories, Inc. Fort Worth, Texas 76134 for Sandoz Inc., Princeton, NJ 08540, Product of Argentina.
by Sandoz Inc
- Reason
- Labeling: Incorrect or missing package insert.
- Published
- November 6, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Lyophilized Human Chorionic Gonadotropin 5,500 USP Units For injection, Rx Only, Compounded by: Innoveix Addison, TX 75001 800-370-1910
by Innoveix Pharmaceuticals Inc
- Reason
- Lack of Sterility Assurance.
- Published
- November 6, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Estradiol Vaginal Inserts USP, 10 mcg, packaged in a) 8-count Vaginal Inserts (with disposable applicators) per carton (NDC 68462-711-71) and b) 18-count Vaginal Inserts (with disposable applicators) per carton (NDC 68462-711-88), Rx only, Manufactured by: Glenmark Pharmaceuticals Ltd., Colvale-Bardez, Goa 403 513, India; Manufactured for: Glenmark Pharmaceuticals Inc., Mahwah, NJ 07430.
by Glenmark Pharmaceuticals Inc., USA
- Reason
- Defective Delivery System: complaints for difficulty in pushing the plunger of the applicator.
- Published
- November 6, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Prasugrel Tablets 5 mg, 30-count bottles, Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A, NDC 0378-5185-93
by Mylan Pharmaceuticals Inc.
- Reason
- Failed Dissolution Specification: Low out of specification dissolution results.
- Published
- November 6, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
PF-Succinylcholine Chloride Injection, USP 20 mg/mL (200 mg/10 mL), Rx Only, Single-Dose Container, 5 x 10 mL pre-filled syringes, Nephron 503B Outsourcing Facility 4500 12th St. Ext West Columbia, SC 29172, NDC 69374-919-10.
by Nephron Pharmaceuticals Corporation dba Nephron Sterile Compounding Center
- Reason
- Incorrect labeling: Incorrect or missing lot and/or exp date
- Published
- November 6, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Povidone Iodine, 5% Ophthalmic Solution, 5 mL per droptainer, Repackaged by: Avella Specialty Pharmacy, 24416 N. 19th Ave., Phoenix, AZ 85085. NDC 42852-006-20
by Avella of Deer Valley, Inc. Store 38
- Reason
- Lack of sterility assurance.
- Published
- October 30, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
del Nido Cardioplegia Solution, 1000 mL, Single-Dose Container, Rx Only Nephron 503B Outsourcing Facility 4500 12th St. Extension West Columbia, SC 29172 NDC: 69374-984-10
by Nephron Pharmaceuticals Corporation dba Nephron Sterile Compounding Center
- Reason
- Lack of Assurance of Sterility; bags have potential to leak
- Published
- October 30, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Amino Acid Injection 50 g/1000 mL (50 mg/mL) 25 g L-Arginine HCl; 25 g L-Lysine HCl, Single Dose Container, Rx Only Nephron 503B outsourcing facility 4500 12th St. Extension West Columbia, SC 29172 NDC: 69374-988-10
by Nephron Pharmaceuticals Corporation dba Nephron Sterile Compounding Center
- Reason
- Lack of Assurance of Sterility; bags have potential to leak
- Published
- October 30, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
PF-Fentanyl Citrate 2 mcg/mL* & Ropivacaine HCl 0.1% in 0.9% Sodium Chloride Injection-200 mL Total Dose: (400 mcg/200 mg)/200 mL, Rx Only Nephron 503B Outsourcing Facility 4500 12th St. Extension West Columbia, SC 29172 NDC: 69374-526-20
by Nephron Pharmaceuticals Corporation dba Nephron Sterile Compounding Center
- Reason
- GMP Deviations: potential glass contamination
- Published
- October 30, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
PF-Fentanyl Citrate 2 mcg/mL* & Bupivacaine HCl 0.125% in 0.9% Sodium Chloride Injection-250 mL, Rx Only Total Dose: (500 mcg/312.5 mg)/250 mL, Nephron 503B Outsourcing Facility 4500 12th St. Extension West Columbia, SC 29172 NDC: 69374-530-25
by Nephron Pharmaceuticals Corporation dba Nephron Sterile Compounding Center
- Reason
- GMP Deviations: potential glass contamination
- Published
- October 30, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
PF-Fentanyl Citrate (2 mcg/mL)* & Bupivacaine HCl 0.0625 in 0.9% Sodium Chloride Injection-250 mL Total Dose: (500 mcg/156.3 mg)/250 mL, Rx Only, Nephron 503B Outsourcing Facility 4500 12th St. Extension West Columbia, SC 29172 NDC 69374-0525-25
by Nephron Pharmaceuticals Corporation dba Nephron Sterile Compounding Center
- Reason
- GMP Deviations: potential glass contamination
- Published
- October 30, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass III
Threshold Enterprises Ltd
- Product
- Source Naturals Dietary Supplement Brain Charge Advanced…
- Reason
- Labeling error; incorrect supplement facts panel and label claims for two ingredients were lower than the product formulation.
- Published
- October 30, 2019
- Distribution
- U.S. distribution to the following: AL,…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
The Truck Farm, LLC
- Product
- Tia Rita's Spicy Southwestern Green Chile Cornbread dry mix.…
- Reason
- The product contains wheat flour, but does not declare wheat on the label.
- Published
- October 30, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Leucovorin Calcium Injection, USP 500 mg*/50 mL (10 mg/mL) 50 mL Single-Dose Vial NDC 50742-464-50 Rx Only Ingenus Pharmaceuticals, LLC. Orlando, FL 32839
by Ingenus Pharmaceuticals Llc
- Reason
- Crystallization: Presence of particulate matter identified as API crystallization
- Published
- October 23, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Pantoprazole Sodium Delayed Release Tablets, USP, 40 mg, packaged in 90-count bottle, Rx only, Manufactured by: Jubilant Generics Ltd, Roorkee - 247661, India, Marketed by: Jubilant Cadista Pharmaceuticals Inc., Salisbury, MD 21801, NDC 59746-284-90
by Jubilant Cadista Pharmaceuticals, Inc.
- Reason
- CGMP Deviation: Presence of dark brown discoloration on edges of tablets.
- Published
- October 23, 2019
- Distribution
- Product was distributed to MS, OH, RI, T…
View recall →
FDA Recall
Terminated
Historical recordClass II
Dextroamphetamine Sacharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, Mixed Salts of a single Entity Amphetamine Product), 20mg, 100-count bottle, RX Only, Distributed by: Aurobindo Pharma USA Inc., Dayton, NJ 08810, NDC 13107-073-01
by Aurobindo Pharma USA Inc.
- Reason
- Superpotent Drug: Amphetamine Mixed Salts 20mg have been found to be out of specification for weight and thickness.
- Published
- October 23, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Methylphenidate Hydrochloride Oral Solution 5mg per 5mL, 500 mL Bottle, Sugar Free Alcohol Free, Rx Only, Mfd by: KVK Tech, Inc., Newtown, PA 18940, NDC 10702-0163-50.
by KVK-Tech, Inc.
- Reason
- Presence of Foreign Substance; Fiber particles.
- Published
- October 23, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
E.A. Sween Co.
- Product
- Market Sandwich Artisan Style Albacore Tuna Salad on Dark Wh…
- Reason
- Various sandwiches have the potential to be contaminated with Listeria monocytogenes.
- Published
- October 23, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
E.A. Sween Co.
- Product
- Tuna Salad on Wheat Bread, Keep Refrigerated. packaged un…
- Reason
- Various sandwiches have the potential to be contaminated with Listeria monocytogenes.
- Published
- October 23, 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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