Recalls That Should Be on Your Radar—Week of December 15, 2019
We’ve round up a list of important US Food and Drug Administration (FDA) and US Department of Agriculture (USDA) recalls from this past week.
Lannett Company, Inc. Issues Recall of Levetiracetam Oral Solution Due to Microbial Contamination
Lannett Company, Inc. has issued a voluntary nationwide recall of 2 lots of Levetiracetam Oral Solution, 100 mg/ml, due to contamination with Bacillus subtilis.
Levetiracetam is indicated for treatment of patients with partial-onset seizures. The problem was discovered during evaluation of raw material used to manufacture the product.
Bacillis Subtilis has low pathogenic potential, but serious infections have been reported in the past. Lannett has not received reports of any adverse events related to the recall.
Read the recall statement.
Montpak International Inc. Issues Recall of Lamb and Veal Products Produced Without Benefit of Import Inspection
Montpak International Inc., a Canadian firm, has issued a recall for approximately 2804 pounds of lamb and veal products that were not presented for import re-inspection into the United States.
Products related to the recall bear establishment number “CANADA 96” in the Canadian mark of inspection or “EST 1809” on the box. Items were sent to distributors in New Jersey, New York, and Virginia.
The problem was discovered during routine Food Safety and Inspection Service surveillance. There have been no confirmed reports of adverse reactions connected to the recall.
Read the recall statement.
Glenmark Pharmaceuticals Inc. Issues Recall of All Ranitidine Tablets Due to Possible N-nitrosodimethylamine Impurity
Glenmark Pharmaceuticals Inc. has issued a voluntary recall of all unexpired lots of Ranitidine tablets, 150 mg and 300 mg due to the potential presence of N-nitrosodimethylamine levels above acceptable daily intake levels.
N-nitrosodimethylamine is classified as a probable human carcinogen. Glenmark has not received any reports of adverse events confirmed related to the recall.
Read the recall statement.
Alli & Rose, LLC Issues Recall of Siluriformes Fish Products Produced Without Benefit of Import Inspection
Alli & Rose, LLC, a California firm, has issued a recall of approximately 21,930 pounds of Siluriformes products not presented for import re-inspection. The products were also imported from Thailand, a country ineligible to export ready-to-eat Siluriformes products to the United States.
Products were shipped to retailers in California, Maryland, and New Jersey. The problem was discovered during routine Food Safety and Inspection Service surveillance of imported products.
There have been no confirmed reports of adverse reactions related to these products. Consumers who have purchased the products are advised to throw them away.
Read the recall statement.
Motto International Corp. Issues Recall of Products Due to Undeclared Tadalafil
Motto International Corp. has issued a voluntary recall of all lots of Bull Platinum 30000, Stallion Platinum 30000, Rhino 7 Platinum 30000, and Panther Platinum 30000 male sexual enhancement dietary supplements due to the presence of tadalafil.
Tadalafil is an FDA approved drug, making the products affected by the recall unapproved drugs for which safety and efficacy has not been established.
Consumption of a product with undeclared tadalafil may pose risks for consumers who take prescription medicine containing nitrates.
To date, Motto International Corp. has not received reports of any adverse events connected to the recall.
Read the recall statement.
LivaNova Issues Recall of VNS Therapy SentTiva Generator Due to Reset Error
LivaNova has issued a recall of the VNS Therapy SenTiva Generator System, used for Vagus Nerve Stimulation to reduce the frequency of seizures in adults and children over 4 years of age with partial onset seizures. The device is also used in the treatment of major depressive episodes in patients who have not responded to antidepressant medications.
The recall is related to an unintended reset error in which the system stops delivering VNS therapy. If device replacement is needed, there is risk associated with additional surgery.
LivaNova has received 14 reports of reset errors, with 4 patients requiring early revision surgery for failed devices. No deaths connected to the issue have been reported.
On July 31, 2019, the firm implemented additional mitigations and no further reset errors have been observed. The additional mitigations are currently under FDA review.
Read the recall statement.
