Urgent medicine recall: FLUOXETINE SANDOZ fluoxetine (as hydrochloride) 20mg capsule blister pack

The Therapeutic Goods Administration (TGA) has issued an urgent medicine recall for FLUOXETINE SANDOZ fluoxetine (as hydrochloride) 20mg capsule blister pack.

The product sponsor has been notified that 13 batches have been affected by the N-Nitroso-fluoxetine impurity.

Product Details

Batch numbers: JV6910, JV6911, KC8064, KA3731, KA3730, KJ0379, KR9213, KV1965, KV2309, KT9869, KT 9870, KZ2586, KZ2588.
Expiry dates: 05-2024, 05-2024, 09-2024, 09-2024, 09-2024, 01-2025, 03-2025, 05-2025, 05-2025, 07-2025, 07-2025, 08-2025, 08-2025.
ARTG: 64564 (FLUOXETINE SANDOZ fluoxetine (as hydrochloride) 20mg capsule blister pack)
Sponsor: Sandoz Pty Ltd

Actions

Pharmacies are advised to inspect stock immediately, quarantine all impacted stock, and contact their wholesaler to organise stock return and a credit note.

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