PlainRecalls
FDA Drug Low Class III Terminated

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.

Reported: April 25, 2018 Initiated: April 6, 2018 #D-0631-2018

Product Description

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.

Reason for Recall

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

Details

Recalling Firm
Sandoz Incorporated
Units Affected
11,680 bottles
Distribution
Nationwide in the USA and Puerto Rico
Location
Broomfield, CO

Frequently Asked Questions

What product was recalled?
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.. Recalled by Sandoz Incorporated. Units affected: 11,680 bottles.
Why was this product recalled?
Cross Contamination With Other Products: presence of unrelated ingredients (i.e. traces of Lisinopril, Mannitol, Iron, Calcium and Phosphorous).
Which agency issued this recall?
This recall was issued by the FDA Drug on April 25, 2018. Severity: Low. Recall number: D-0631-2018.