Saline solution products recalled over bacterial contamination fears
Several batches of saline solution-based healthcare products have been recalled due to an investigation into their “potential” microbiological contamination.
The UK’s medicines watchdog has warned that a “potential contamination with Ralstonia pickett (R. pickettii) has been identified in 0.9% sodium chloride solutions used for irrigation, inhalation and eye wash”.
The recalled batches were manufactured by Legency Remedies Pvt Ltd between April and November 2023. See the lot or serial numbers of the recalled products below.
R. pickettii is a kind of bacteria that can contaminate healthcare products such as saline solution.
Yesterday (April 4), the Medicines and Healthcare products Regulatory Agency (MHRA) said that while cases of R. pickettii are "rare" in the UK, the bacteria can lead to “opportunistic infections” in “individuals with compromised immune systems”.
The MHRA added that three cases of R. pickettii have been confirmed in the UK since April 3, and a “small number of other cases are under investigation”.
It confirmed that the cases “have been linked to contaminated saline products”.
“All confirmed cases received treatment and recovered,” it stressed.
“Immediately stop use, quarantine and stop supply”
Manufacturer Legency Remedies Pvt Ltd “identified through testing that seven batches of 0.9% sodium chloride irrigation solution have not met sterility standards”, the MHRA said.
“These batches were removed and disposed of before being sold in the UK” but the manufacturer has recalled all 0.9% sodium chloride solutions, “as a precautionary measure”, it said.
The MHRA told all healthcare providers to review their inventory and “immediately stop use, quarantine and stop supply of any identified product”.
The affected lot or serial numbers are:
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2358022E
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2358023E
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2358024E
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2358025E
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2358026E
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2358027E
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2358028E
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2358016E
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2358017E
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2358018E
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2358019E
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2358020E
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2358021E
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2358022E
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2358023E
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2358024E
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2358025E
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2358026E
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2358027E
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2358028E
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2358029E
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2358030E
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2358031E
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2358031E
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2358033E
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2358034E
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2358035E
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2358036E
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2358036E
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2358042E
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2358043E
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2358044E
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2358045E
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2358046E
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2358047E
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2358048E
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2358049E
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2358050E
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2358050E
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2358050E
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2358050E
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2358050E
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2358050E
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2358056E
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2358056E
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2358070E
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2358071E
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2358072E
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2358073E
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2358074E
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2358075E
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2358076E
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2364043E
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2364044E
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2364045E
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2364046E
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2364047E
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2364048E
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2364049E
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2364050E
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2364051E
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2364052E
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2364053E
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2364054E
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2364055E
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2364056E
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2364056E
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2364058E