Macleods Pharma Usa Inc 2022-05-11 Health serious FDA
Health · FDA · Recall #FDA-D-0835-2022
Losartan Potassium & Hydrochlorothiazide Tablets, USP, 50 mg/12.5 mg, a) 30-count bottles… Recall
Issued May 11, 2022 · Macleods Pharma Usa Inc
In May 2022, Macleods Pharma Usa Inc recalled the Losartan Potassium & Hydrochlorothiazide Tablets, USP, 50 mg/12.5 mg, a) 30-count bottles…, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
What you should do
- 1 Stop using Losartan Potassium & Hydrochlorothiazide Tablets, USP, 50 mg/12.5 mg, a) 30-count bottles… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Macleods Pharma Usa Inc to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- Macleods Pharma Usa Inc
- Category
- Health
- Recall date
- May 11, 2022
- Units affected
- Not reported
- Sold at
- Product was distributed nationwide.
- Recall number
- FDA-D-0835-2022
- Made in
- United States
- Issuing agency
- FDA
In context
- Macleods Pharma Usa Inc has 6 recalls in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 870th Health recall we've logged in 2022.