Recall of 10 Wockhardt UK medicines
The MHRA has recalled five Wockhardt UK POMs following the discovery of deficiencies at its manufacturing site. Wockhardt has also issued a precautionary recall of five OTC medicines
The MHRA has recalled five prescription-only medicines (POMs) made by Wockhardt UK because of "deficiencies" at its manufacturing site.
The recall, from pharmacies and wholesalers but not patients, includes the antibiotic clarithromycin and type 2 diabetes treatment gliclazide. It was issued today (October 17) following an inspection of Wockhardt UK's manufacturing site in Chikalthana in India in July.
The inspection revealed poor recording keeping relating to the manufacture and testing of medicines and inadequate validation and production controls, the medicines watchdog said.
Wockhardt UK also issued its own precautionary recall of five over-the-counter medicines today, including aspirin, paracetamol and ibuprofen.
Today's recalls come three months after the MHRA recalled 16 Wockhardt UK POMs following fears of contamination at another of the company's manufacturing sites in India.
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The MHRA said at the time that a routine inspection of its Waluj site had found a "low risk of cross-contamination" because of poor cleaning practices and defects in the building and its ventilation systems. Wockhardt UK told C+D that none of the faults found by the MHRA were "critical in nature" and said that there was no evidence of any risk to patient safety. The MHRA said today it was working with Wockhardt UK and other international regulators to resolve the issue. There are still 10 POMs being manufactured at the Chikalthana site and supplied to UK patients because of shortage concerns. The MHRA stressed that patients did not need to return their affected medicines because there was no evidence that they were defective and that most of the affected medicines were available from alternative manufacturers. MHRA director of inspection, enforcement and standards Gerald Heddell said: "People can be reassured that there is no evidence of a safety risk from the medicines made at Wockhardt UK's Chikalthana site, so it's important people continue to take their medicines as prescribed." |
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Drugs recalled by the MHRA● Amiloride HCl 5mg tablets PL 29831/0006 ● Clarithromycin 250mg tablets PL 29831/0476 ● Clarithromycin 500mg tablets PL 29831/0477 ● Gliclazide 80mg tablets PL 29831/0103 ● Quinine sulphate 300mg tablets PL 29831/0182 ● Tamsulosin pinexel 400mcg tablets PL 29831/0366 Drugs recalled by Wockhardt UK● Aspirin 300mg tablets Wockhardt UK and Co-op livery – PL 29831/0015 ● Extra pain control caplets Co-op livery – PL 29831/0164 ● Ibuprofen 200mg caplets Superdrug livery – PL 29831/0289 ● Max strength cold & flu relief Superdrug livery – PL 29831/0169 ● Paracetamol extra strength tablets Best In, Galpharm, Happy Shopper and Spar livery – PL 29831/0166 Stocks should be quarantined and returned to the original supplier for credit. Contact Wockhardt UK customer services on 01978 661261 or email [email protected] |
