Medicine recalls
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| The United States: Batch recall of Normosol-M and 5% Dextrose Injection due to mislabeling of expiry date |
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The Food and Drug Administration (FDA) announced that Hospira Inc initiated a voluntary recall of one lot of Normosol-M and 5% Dextrose (multiple electrolytes and 5% dextrose) Injection Type 1, USP, 1000 mL Single-Dose Container bag (Lot #: 56-853-FW, Exp 01AUG2017). A total of 10,778 bags had been distributed nationwide and to Hong Kong.
Reason for the recall was labeling error: incorrect or missing Lot and/or Exp Date. There was a confirmed customer report of an incorrect expiration date printed on the primary container labeled ''01AUG1017'' rather than ''01AUG2017''.
Please refer to the following website in FDA for details:
http://www.accessdata.fda.gov/../enforce_rpt-Product-Tabs.cfm?action=select&recall_number=D-0727-2016&..&lang=eng
In Hong Kong, Normosol-M & 5% Dextrose Inj Plastic (HK-32659) is a pharmaceutical product registered by Hospira Limited which is a subsidiary of Pfizer Corporation Hong Kong Ltd (Pfizer). On 2 February 2016, Pfizer notified the Department of Health (DH) of the above incident, and voluntarily recalled the affected batch from the market. The news was posted on the Drug Office website on the same day. According to Pfizer, about 3,394 bags (each bag containing 1,000ml) from the affected batch have been supplied to the 4 private hospitals and one private clinic. So far, DH has not received any adverse drug reaction case related to the product. Pfizer has already completed the recall.
Ends/ Monday, March 07, 2016
Issued at HKT 15:00
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