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Warning letters, 483s, Recalls, Import Alerts, Audit observations
Abbot recalls all batches of Digene Gel of all flavours (Mint, Orange, Mix fruit flavours) in India. The recall follows a customer complaint about a bottle of Digene Gel which was white in colour, and with bitter taste and pungent odour. Initially Abbot recalled 5 batches of Digene Gel (Mint flavour and Orange flavour) and stopped production of Digene Gel at the Goa facility. Further the recall was extended to all batches of Digene Gel in the market which are within shelflife. The recall applies to all batches of Digene Gel manufactured at Abbot facility at Salcette, Goa (India) facility of Abbot.
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