Class II · Moderate risk
Admelog
Lack of Assurance of Sterility: Malformed crimped collar seal
Elitek (rasburicase)
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Failed Stability Specifications: Out of Specification result for enzyme activity levels noted during routine stability testing.
Cause type: Stability / shelf life
The product degraded or failed stability testing before its labeled expiry. Heat, moisture or time can break the drug down into degradants or reduce potency. All stability / shelf life recalls.
What was recalled
Elitek (rasburicase) for injection, 7.5 mg vial, Rx Only Mfd. by Sanofi - Aventis U. S. LLC Bridgewater, NJ, 08807, NDC 0024-5151-75
Affected NDC
0024-5151-75
Compare with the code on your package — it is the most precise check available.
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Elitek rasburicase NDC 00024-5151 |
Kit | Sanofi-Aventis U.S. LLC | Rx |
- Recalling firm
- Sanofi-Aventis U.S. LLC
- NDC code
- 0024-5151-75
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1507-2020 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall.
Other recalls by Sanofi-Aventis U.S. LLC
All 2020 recalls
Class II · Moderate risk
Zantac 75 mg
CGMP Deviations: Presence of NDMA impurity detected in product.
Class II · Moderate risk
Zantac 150 mg
CGMP Deviations: Presence of NDMA impurity detected in product.
Class II · Moderate risk
Regular Strength Zantac 75 mg
CGMP Deviations: Presence of NDMA impurity detected in product.
Other stability / shelf life recalls from 2020
All stability / shelf life recalls
Class II · Moderate risk
Phentermine
cMGP Deviations: Drug products repackaged into pouches without supporting stability studies.
Class II · Moderate risk
Diethylpropion
cMGP Deviations: Drug products repackaged into pouches without supporting stability studies.
Class II · Moderate risk
Diethylpropion
cMGP Deviations: Drug products repackaged into pouches without supporting stability studies.
Class II · Moderate risk
Buprenorphine Transdermal System 5 mcg/hour
Failed Stability Specifications: Below specification result for buprenorphine release rate.
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