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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.
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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.
