Perrigo Recalls Tamper-Resistant PSE Product Due To Contamination

FDA on Dec. 21 identified the recall as class II, for violative products that may cause temporary or medically reversible adverse health consequences though the probability of serious consequences is remote. Perrigo acquired the Zephrex-D brand and rights to the formulation in 2016.

The supply of tamper-resistant nonprescription pseudoephedrine formulations in the US is slowed temporarily with Perrigo Co. PLC recalling its Zephrex-D 30 mg product distributed nationwide.

FDA's Dec. 27 update to its recall database indicates that Perrigo recalled nearly 20,000 24-count packages of the softgel tablet...