Sandoz, Inc 2022-04-13 Health serious FDA
Health · FDA · Recall #FDA-D-0753-2022
Orphenadrine Citrate Extended-Release Tablets, USP 100 mg, Rx Only, 100 Tablets,… Recall
Issued April 13, 2022 · Sandoz, Inc
In April 2022, Sandoz, Inc recalled the Orphenadrine Citrate Extended-Release Tablets, USP 100 mg, Rx Only, 100 Tablets,…, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
CGMP Deviations:Nitrosamine impurity (NMOA) above the acceptable daily limit.
What you should do
- 1 Stop using Orphenadrine Citrate Extended-Release Tablets, USP 100 mg, Rx Only, 100 Tablets,… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Sandoz, 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
- Sandoz, Inc
- Category
- Health
- Recall date
- April 13, 2022
- Units affected
- Not reported
- Sold at
- Nationwide
- Recall number
- FDA-D-0753-2022
- Made in
- United States
- Issuing agency
- FDA
In context
- Sandoz, Inc has 1 recall in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 870th Health recall we've logged in 2022.