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.

FDA recall notice · announced April 25, 2018 · Sandoz

Class III FDA/FSIS Class III: use is not likely to cause adverse health consequences.

The 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.

Reason for recall

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

Notes

Distribution: Nationwide in the USA and Puerto Rico
Lot/code information: Lot #: GW8264, HD3095, Exp 12/18
Quantity: 11,680 bottles
Status: Terminated
Products in this recall event:
- 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)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.