Zydus Pharmaceuticals announced a voluntary recall of 10,200 bottles of Promethazine HCl Tablets 25mg. This recall was initiated due to the reported presence of an Atenolol 25mg tablet in a Promethazine HCl 25mg tablet bottle. Atenolol is indicated for the long-term management of angina in adults and hypertension.
The affected 25mg tablets are supplied in 100-count bottles have Lot #MN9081 with an expiration date of 09/15. The recalled lot was manufactured at a Zydus Pharmaceuticals plant in India. The FDA has designated this a Class II recall, in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Promethazine HCl is indicated for the treatment of motion sickness and perioperative nausea and vomiting in children and adults.
For more information call (888) 463-6332 or visit FDA.gov.