The Spanish Agency for Medicines and Healthcare Products (AEMPS), which is part of the Ministry of Health, ordered the withdrawal of batches of three medicines in Spain last month.
AEMPS issued the first two orders on August 30, 2023, for three batches of Ketobrill eye drops and another batch of Apiroserum Normaion Restaurador medical serum. Regarding the first drug, discontinuation affects 0.25 mg/ml single-dose containers (NR: 77213, CN: 697080). The agency has forced the withdrawal of batch 21J004 from the market, which has expired on August 31; 22C049 will expire on February 28, 2024, and 22D022 will expire on March 31.
According to the package insert, Ketobrill “contains the active ingredient ketotifen fumarate, an anti-allergic substance used to treat the eye symptoms of seasonal allergic conjunctivitis (hay fever).”
According to AEMPS, the second withdrawal order was issued against Apiroserum Normaion Restaurador on the same day as the previous one due to the detection of “extra-specification results for one of the excipients used in its production.” “. This alert applies to batch number 19RMB090, which is available in 500 ml bottles (NR: 45434, CN: 614602).
AEMPS also ordered a recall of Ferplex 40 mg oral solution, 20 15 ml drinking bottles (NR: 59587, CN: 776773) on September 12. The agency stipulates that the following batches must be withdrawn from the market due to the following reasons: Result exceeds specification TAMC parameters (Total number of bacteria):
- Batch: 23111, valid until May 31, 2025
- Batch: 23123, valid until June 30, 2025
- Batch: 23124, valid until June 30, 2025
- Batch: 23129, valid until June 30, 2025
- Batch: 23132, valid until June 30, 2025
- Batch number: 23135, valid until July 31, 2025
- Batch: 23136, valid until July 31, 2025
- Batch: 23141, valid until July 31, 2025
- Batch number: 23155, valid until July 31, 2025
- Batch: 23162, valid until July 31, 2025
- Batch: 23164, valid until July 31, 2025