FDA Recalls September 8 - 13

Drug Recalls

Novartis Issues Voluntary Nationwide Recall of One Lot of Sandimmune® Oral Solution (Cyclosporine Oral Solution, USP), 100 mg/mL Due to Crystallization

FOR IMMEDIATE RELEASE – September 11, 2023 - East Hanover, NJ — Novartis is conducting a voluntary nationwide recall at the consumer level of one lot of its Sandimmune® Oral Solution (cyclosporine oral solution, USP), 100 mg/mL in the US due to crystal formation observed in some bottles, which could potentially result in incorrect dosing. No other Sandimmune formulations are impacted.

Sandimmune® Oral Solution (cyclosporine oral solution, USP), 100 mg/mL, packaged in 50 mL bottles, is indicated for the prophylaxis of organ rejection in kidney, liver, and heart allogeneic transplants. The drug may also be used in the treatment of chronic rejection in patients previously treated with other immunosuppressive agents.

Church & Dwight Initiates Voluntary Recall of One Specific Lot of TheraBreath Kids Strawberry Splash 16oz Sold Exclusively on Amazon Between May 31 and September 02, 2023, Due to an Isolated Manufacturing Issue

FOR IMMEDIATE RELEASE – September 8, 2023 – EWING, N.J – Church & Dwight Co., Inc. (NYSE:CHD) today initiated a voluntary recall of one specific lot of TheraBreath Kids Strawberry Splash 16oz after the Company identified a microbial contamination due to the presence of yeast (Candida Parapsilosis) in lot #PA3083011 of TheraBreath Kids Strawberry Splash 16 oz, sold exclusively on Amazon between May 31 and September 02, 2023.

Hua Da Trading Inc dba Wefun Inc Issues Voluntary Nationwide Recall of WEFUN Capsules Due to Presence of Undeclared Sildenafil

FOR IMMEDIATE RELEASE – 08/25/2023 – Brooklyn, New York, Hua Da Trading Inc dba Wefun Inc is voluntarily recalling 300 Boxes of WEFUN Capsules to the consumer level. FDA analysis has found the product to be tainted with sildenafil. Sildenafil is an ingredient known as a Phosphodiesterase Inhibitor (PDE-5) inhibitor found in FDA-approved products for the treatment of male erectile dysfunction. The presence of sildenafil in this product renders it an unapproved drug for which the safety and efficacy has not been established and, therefore, subject to recall.

Food & Beverage Recalls

Sheng Kee of California, Inc. Issues Allergy Alert on Undeclared Egg in the Following Traditional Mooncake Products

• Small 12 – 3 Flavor Assorted Mooncake Gift Box (Expires 10/29/23)
  • Batch Number(s): 2UJ4N, 2UJ8N, 1UJ4L, 2UJ5N
• Small 12 – 4 Flavor Assorted Mooncake Gift Box (Expires 10/29/23)
  • Batch Number(s): 2UJ8N, 3UJ0N, 0UJ1L, 0UJ2L, 1UJ2L, 2UJ7L, 2UJ9N
• Small 12 – 6 Flavor Assorted Mooncake Tin Gift Box (Expires 10/29/23)
  • Batch Number(s): 0UJ7L
• Small 12 – Tea Flavor Assorted Mooncake Gift Box (Expires 10/29/23)
  • Batch Number(s): 0UJ5L, 0UJ6L
• Small 6 – 3 Flavor Assorted Mooncake Gift Box (Expires 10/29/23)
  • Batch Number(s): 2UJ1N, 2UJ3N, 2UJ7L, 2UJ2N
• Small 9 – 3 Flavor Assorted Mooncake Gift Box (Expires 10/29/23)
  • Batch Number(s): 2UJ1N, 2UJ3N, 2UJ4N, 2UJ7L, 2UJ2N
• Assorted Large 4 Mooncake Gift Box (Expires 10/7/23)
  • Batch Number(s): 1UJ9L
• Large 4 – Date Mooncake Gift Box (Expires 10/7/23)
  • Batch Number(s): 1UJ9L
• Large 4 – Lotus Pine Nut Mooncake Gift Box (Expires 10/7/23)
  • Batch Number(s): 1UJ9L
• Large 4 – Red Bean Mooncake Gift Box (Expires 10/7/23)
  • Batch Number(s): 1UJ9L

Sheng Kee of California, Inc. is voluntarily recalling varieties of Mooncake Gift Boxes for customers that have any issues because they may contain undeclared egg wash. People who have allergies to egg run the risk of serious or life-threatening allergic reaction if they consume these products.

The recalled Mooncakes were distributed nationwide in retail stores and through mail orders. We are working with our wholesalers and retailers to relabel and refit the current boxes.

OBC Group Corp Recalls Nuez de la India Seeds and Capsules Products Due to Possible Health Risks

OBC GROUP CORP of, Miami, FL is recalling its NUT DIET MAX Nuez de la India Seeds and Capsules because FDA analysis has determined that the products appear to be Thevetia peruviana, or yellow oleander. All parts of the yellow oleander plant are known to contain cardiac glycosides that are highly toxic to humans and animals. Ingestion of yellow oleander can cause neurologic, gastrointestinal, and cardiovascular adverse health effects that may be severe, or even fatal. Symptoms may include nausea, vomiting, dizziness, diarrhea, abdominal pain, cardiac changes, dysrhythmia, and more.

The product NUEZ DE LA INDIA Seeds was distributed online through Amazon and eBay.  The Seeds comes in a 2-ounce clear bag.  The product NUEZ DE LA INDIA Capsules was distributed online through Walmart and eBay. The Capsules comes in an amber bottle with 30 capsules.

Life Raft Treats Recalls Ice Cream Products, Not Fried Chicken And Life Is Peachy, Due to Possible Listeria Monocytogenes Contamination

NORTH CHARLESTON, SC – September 6, 2023 – Life Raft Treats is recalling their Not Fried Chicken 64 oz bucket, Not Fried Chicken 2.5 oz bar UPC 8 60006 18210 6 and Life Is Peachy 6 count box ice cream products, all with BEST BY DATES up to and including AUG 8212024 due to a potential contamination of Listeria monocytogenes. Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, a Listeria monocytogenes infection can cause miscarriages and stillbirths among pregnant women.

On September 5, 2023 the firm was notified by South Carolina Department of Health and Environmental Control (SCDHEC) that their Not Fried Chicken ice cream treat test positive for Listeria monocytogenes. The firm also decided to recall their Life Is Peachy Ice Cream treats because both products were manufactured in the same room.