Unique Pharma recalls 5 mg cetirizine tablets over possible ranitidine contamination
Unique Pharmaceutical Laboratories, a division of J.B. Chemicals & Pharmaceuticals Ltd., announced a voluntary nationwide recall of four lots of its 5 mg cetirizine hydrochloride tablets.
The recall was triggered by a potential cross contamination with ranitidine, which could cause serious hypersensitivity reactions such as anaphylaxis in patients sensitive to ranitidine. The company said no adverse events have been reported so far.
The affected tablets are packaged in HDPE bottles of 100 tablets (NDC 16571-401-10). Consumers should stop using the product and return it to the pharmacy for a refund or replacement.
This writeup was produced by pharmadog from original reporting by fda medwatch.
Original headline: “Unique Pharmaceutical Laboratories (A Div. of J. B. Chemicals & Pharmaceuticals Ltd.) Issues Voluntary Nationwide Recall of Cetirizine Hydrochloride Tablets USP 5 mg Due to Potential Cross Contamination with Ranitidine”
read at fda medwatch ↗
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