Drug product

Triamterene and Hydrochlorothiazide Tablets, USP, 75 mg/50 mg, 500-count bottles, Rx only, Manufactured by Sandoz, Inc., Princeton, NJ 08540, NDC 0781-5067-05.

D-0631-2018

April 06, 2018

Class III

Product summary

Firm: Sandoz Incorporated
Event: Event 79788
Status: Terminated
Classification: Class III
Quantity: 11,680 bottles
Official record key: drug-enforcement:D-0631-2018

Official wording

Reason: Cross Contamination With Other Products: presence of unrelated ingredients (i.e. traces of Lisinopril, Mannitol, Iron, Calcium and Phosphorous).

Code information: Lot #: GW8264, HD3095, Exp 12/18

Distribution pattern: Nationwide in the USA and Puerto Rico

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

Cross Contamination With Other Products: presence of unrelated ingredients (i.e. traces of Lisinopril, Mannitol, Iron, Calcium and Phosphorous).