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AMK · Batch recall · Germany
Batch recall: Nystatin acis Mundgel 100.000 I.E./g Gel, 25 g
Batch recall for Nystatin acis Mundgel 100.000 I.E./g Gel, 25 g, published 14/08/2026. Product-specific German AMK notice with pharmacy, pharmaceutical wholesale and QMS context.
Published: · Data source: AMK
Interpretation and publisher: tiger.PHARMA · Updated:
Pharmaceutical interpretation of the notice
The notice concerns specific batches. The product name alone is insufficient: batch number, pack, German PZN and physical stock determine the operational scope.
- Product in notice
- Nystatin acis Mundgel 100.000 I.E./g Gel, 25 g
- Notice type
- Batch recall
- Published
- 14/08/2026
Impact on pharmacy inventory and operations
Match product, German PZN, pack and batch against the pharmacy system, physical stock, reservations and previously supplied packs. Segregate or block affected stock as specified. Ownership, customer communication, returns and closure should be documented in the pharmacy QMS.
Impact on pharmaceutical wholesale and GDP
Pharmaceutical wholesalers need to reconcile ERP and WMS data, storage locations, batch stock, customer deliveries, returns and goods in transit. The Responsible Person governs GDP action, traceability, communication, effectiveness checks and documented closure.
Assess recall scope and availability separately
A recall notice does not automatically establish a shortage of the entire medicine. Remaining released batches, other packs, confirmed wholesale stock, allocations and supplier responses require a separate availability review.
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Pharma consulting for Germany and Europe →
Pharmaceutical consulting for manufacturers, wholesalers and logistics teams: align medicines procurement, product data, quality responsibilities and distribution, with a defined project scope and implementation steps.
Pharmacy QMS and recall procedures →
Document notice review, batch reconciliation, stock segregation, returns and closure with defined responsibilities and evidence.
Source and professional note
This page reproduces publicly available product and notice data. Check the original AMK notice and operational procedures for affected batches, risk assessment and binding action.
Data source: AMK · Published: 14/08/2026