Zydus Pharmaceuticals USA Inc recalls PROMETHAZINE HYDROCHLORIDE Tablets, USP, 25 mg, 100 Tablet Bottles, Rx Only. Manufactured by: Cadila Healthcared Ltd.,
Recalled May 28, 2014 · FDA recall D-1342-2014 · Zydus Pharmaceuticals USA
Hazard
Presence of Foreign Tablets: Presence of atenolol 25 mg tablet mixed into promethazine 25 mg tablet bottles. · FDA Class II
Units
10,200 bottles
Sold at
Nationwide
Description
Presence of Foreign Tablets: Presence of atenolol 25 mg tablet mixed into promethazine 25 mg tablet bottles.
Product
PROMETHAZINE HYDROCHLORIDE Tablets, USP, 25 mg, 100 Tablet Bottles, Rx Only. Manufactured by: Cadila Healthcared Ltd., India. Distributed by: Zydus Pharmaceuticals USA Inc., Pennington, NJ 08534. NDC: 68382-041-01
Manufacturer(s)
Zydus Pharmaceuticals USA Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →