D-0631-2018 Class III Terminated
FDA drug recall D-0631-2018 was initiated by Sandoz Incorporated on April 6, 2018 and is designated Class III. Reason for recall: Cross Contamination With Other Products: presence of unrelated ingredients (i.e. traces of Lisinopril, Mannitol, Iron, Calcium and Phosphorous). The recall status is terminated (terminated April 8, 2019). Affected quantity: 11,680 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- April 25, 2018
- Initiation Date
- April 6, 2018
- Termination Date
- April 8, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 11,680 bottles
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).
Distribution Pattern
Nationwide in the USA and Puerto Rico
Code Information
Lot #: GW8264, HD3095, Exp 12/18