The Spanish Agency for Medicines and Health Products (AEMPS) has ordered the withdrawal from the market of several presentations of ‘Duloxetine Pensa Pharma gastro-resistant hard capsules EFG‘, from Towa Pharmaceutical, SA, for the detection of an impurity above its established limit, although it points out that “it represents a vital risk for the patient.”
It’s about the presentations ‘Duloxetine Pensa Pharma 30 mg hard gastro-resistant capsules EFG‘, 7 capsules (PVC/PVDC-aluminum blister) (NR: 79370, CN: 704748) Lot: 220499, expiration date 02/28/2025.
‘Duloxetine Pensa Pharma 30 mg hard gastro-resistant capsules EFG’, 28 capsules (PVC/PVDC-aluminum blister) (NR: 79370, CN: 704749) Lot: 220147, expiration date 01/31/2025.
‘Duloxetine Pensa Pharma 60 mg hard gastro-resistant capsules EFG’28 capsules (PVC/PVDC-aluminum blister) (NR: 79371, CN: 704751) Lot: 220082, expiration date 01/31/2025 Lot: 220151, expiration date 01/31/2025.
‘Duloxetine Pensa Pharma 60 mg hard gastro-resistant capsules EFG’, 56 capsules (PVC/PVDC-Aluminum) (NR: 79371, CN: 706553) Lot: 220393, expiration date 02/28/2025.
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