Recall: Two Lots of Quinapril and Hydrochlorothiazide 20mg/12.5mg Tablets, Due to the Detection of N-Nitroso Quinapril Impurity
On October 24, 2022, Aurbindo USA, Inc. initiated a voluntary recall of two lots (refer table below) of Quinapril and Hydrochlorothiazide Tablets USP 20mg / 12.5mg, to the consumer level from the US market due to presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso-Quinapril above the proposed interim limit.
Aurobindo Pharma USA, Inc. began shipping of the subject batches, QE2021005-A and QE2021010-A to customers nationwide May 2021.
|NDC No.||Product Name, strength, and pack||Lot number||Expiry|
|65862-162-90||Quinapril and Hydrochlorothiazide
Tablets USP, 20mg / 12.5mg,
90's HDPE bottle
Any general questions regarding the return of this product please contact Qualanex at 1-888-504-2014 (live calls received 8:00 am to 5:00 pm M-F EST).
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
- FDA MedWatch. Recalls, Market Withdrawals, & Safety Alerts. Retrieved October 26, 2022 from https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/aurobindo-pharma-usa-inc-initiates-voluntary-nationwide-recall-two-2-lots-quinapril-and?utm_medium=email&utm_source=govdelivery