Reported Sep 23, 2015 · Terminated
Dexpanthenol 250 mg/ml Injectable, ml Multi-Dose Vial, Sterile, Refrigerate, The Compounding Pharmacy of America,…
The Compounding Pharmacy of America
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: The Compounding Pharmacy of America · 6216 Highland Place Way Ste 101-A · Knoxville, TN · 37919-4068
Is this the product you have?
- Dexpanthenol 250 mg/ml Injectable, ml Multi-Dose Vial, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN
- Lot codes and dates
- All lots distributed between November 2014 and May 2015; 03122015@25, 6/10/2015; 03202015@31, 6/18/2015; 03172015@42, 6/15/2015; 03232015@5, 6/21/2015; 04162015@15, 7/15/2015
- Amount recalled
- 262 mL total volume
This recall covers 382 products
The agency filed one notice per product. You are reading one of them; the other 381 are below.
369 more are in the archive.
Where it was sold
- Nationwide
Why it was recalled
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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