europeanpharmaceuticalreviewJuly 24, 2020
Tag: MHRA , Nitrofurantoin 50mg tablets , Desmopressin nasal spray
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has announced two Class 2 medicine recalls.
Nitrofurantoin 50mg tablets
Dr Reddy’s Laboratories (UK) Limited is recalling all unexpired stock of a specific batch of Nitrofurantoin 50mg Tablets (PL 08553/0087, EL (20)A/28) from pharmacies and wholesalers as a precautionary measure due to out of specification results for dissolution during routine stability testing.
The MHRA has advised healthcare professionals to stop supplying the batch immediately, quarantine all remaining stock and return these to the supplier using the supplier’s approved process.
Desmopressin nasal spray (all strengths)
Ferring Pharmaceuticals Limited is recalling all unexpired stock of Desmopressin nasal spray (PL 03194/0024, PL 03194/0090, PL 03194/0056, EL (20)A/29) from pharmacies and wholesalers as a precautionary measure due to a lower volume of solution being observed in the bottles and out of specification results for the content of the desmopressin acetate (active substance) and benzalkonium chloride (excipient).
The MHRA has advised healthcare professionals to stop supplying the batches immediately, quarantine all remaining stock and return these to the supplier using the supplier’s approved process.
More information on this recall can be found here.
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