Ranbaxy Laboratories is voluntarily recalling almost 30,000 blister packs of its over-the-counter allergy medication.
The FDA said the recall was due to "an unacceptable level of blister defects," or problems with the pills' packaging.
These medications are generic versions of Claritin, called loratadin, specifically the slow-release pills with added decongestant. The recall affects drugs sold in California, Ohio, Pennsylvania, Rhode Island, and Texas, and bear an expiration date of September 2015.
The FDA's full description of the product is "Non-Drowsy 24 Hour Formula Allergy Relief and Nasal Decongestant, Pseudoephedrine Sulfate, USP 240 mg, Loratadine, USP, 10 mg, 5, 10, 15 count blister packs, OTC Only."
These blister packs were sold at or under the labels of CVS, Discount Drug Mart, Kroger, Sunmark, Good Neighbor Pharmacy, H-E-B, and Rite Aid.
The pills originated at Ohm Laboratories in New Jersey. "Product recalls are not unusual," notes The Wall Street Journal, though, according to Reuters, "all other Ranbaxy plants, based in India, have been banned from exporting generics to the United States after the FDA found manufacturing quality glitches."
This is a Class II recall, which means that using the defective product "may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote."
When we reached out to Ranbaxy for comment, a spokesperson clarified via email that the recall was initiated on February 7, even though it was just made public by the FDA. Here is Ranbaxy's official announcement about the recall:
Loratadine/Pseudoephedrine Sulfate Extended Release Tablets in Blisters, 10/240 mg: VOLUNTARY RECALL
On Friday, February 7th, 2014, Ohm Laboratories Inc., in cooperation with the U.S. Food and Drug Administration, initiated a voluntary recall to the retail level of 2 limited lots (lot numbers are 2554936 and 2554938) of Loratadine/Pseudoephedrine Sulfate Extended Release Tablets, 10/240 mg, fully packaged in blisters. This recall was prompted because batches might contain defective blisters.
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