The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories 2023-12-27 Health critical FDA
Health · FDA · Recall #FDA-D-0153-2024
Phenytoin Oral Suspension, USP, 100 mg/4 mL, packaged in packaged in 4 mL unit dose cups… Recall
Issued December 27, 2023 · The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
In December 2023, The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories recalled the Phenytoin Oral Suspension, USP, 100 mg/4 mL, packaged in packaged in 4 mL unit dose cups…, a critical health recall reported by the FDA. Affected owners are eligible for a voluntary. Here is what the hazard is and exactly what to do about it.
Compiled by Maya Ellison, RecallCheckr
What this means for you
Failed Content Uniformity Specifications
What you should do
- 1 Stop using Phenytoin Oral Suspension, USP, 100 mg/4 mL, packaged in packaged in 4 mL unit dose cups… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories 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
- The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
- Category
- Health
- Recall date
- December 27, 2023
- Units affected
- Not reported
- Sold at
- Nationwide in the USA
- Recall number
- FDA-D-0153-2024
- Made in
- United States
- Issuing agency
- FDA
In context
- The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories has 12 recalls in our database, including 2 rated Critical.
- We're tracking 3,576 Health recalls in our database.
- This is the 903rd Health recall we've logged in 2023.