FDA-Drug2014-05-28Class II
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
Zydus Pharmaceuticals USA Inc
Hazard
Presence of Foreign Tablets: Presence of atenolol 25 mg tablet mixed into promethazine 25 mg tablet bottles.
Sold states
Nationwide
Affected count
10,200 bottles
Manufactured in
73 Route 31 N, N/A, Pennington, NJ, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1342-2014Don't want to check this manually?
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