Class II · Moderate risk
Allopurinol Tablets
Presence of foreign substance.
Aloprim (allopurinol sodium)
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Discoloration: Out-of-specification results for appearance obtained during routine stability testing at the end of shelf-life for the parameters Appearance and Color of Solution.
Cause type: Failed specification
A physical or chemical test other than potency, dissolution, impurity or stability failed - pH, viscosity, appearance, tablet integrity, fill volume. A product outside its own specification may not perform as designed, even if the active ingredient is present. All failed specification recalls.
What was recalled
Aloprim (allopurinol sodium) for Injection, 500 mg Single-Dose Vial, Rx only, Manufactured for: Mylan Institutional LLC, Rockford, IL 61103 USA. NDC: 67457-187-50
Affected NDC
67457-0187-50
Compare with the code on your package — it is the most precise check available.
Drug: Allopurinol
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 |
|---|---|---|---|---|
| Aloprim Allopurinol NDC 67457-0187 |
SODIUM 500 mg/25mL | Injection, Powder, Lyophilized, for Solution Intravenous |
Mylan Institutional LLC | Rx |
- Recalling firm
- Mylan Institutional LLC
- Origin
- IL, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1271-2020 · 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. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Allopurinol recalls
See all
Class II · Moderate risk
Allopurinol Tablets 100mg
Presence of Foreign Substance: manufacturer recalled this re-packaged product due to reports of a small piece of green plastic embedded in the crack towards the edge of the tablet.
Class II · Moderate risk
Allopurinol Tablets USP
Presence of Foreign Substance: Presence of a small piece of green plastic embedded in the crack towards the edge of the tablet.
Class II · Moderate risk
ALLOPURINOL Tablets
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Class III · Low risk
Allopurinol Tablets
Failed Tablet/Capsule Specifications; report of oversized and discolored tablets
Other recalls by Mylan Institutional LLC
All 2020 recalls
Class II · Moderate risk
Levothyroxine Sodium Tablets
Super-Potent Drug: Out of specification potency results were obtained.
Class II · Moderate risk
Levothyroxine Sodium Tablets
Super-Potent Drug: Out of specification potency results were obtained.
Class II · Moderate risk
Levothyroxine Sodium Tablets
Subpotent and Superpotent Drug
Class II · Moderate risk
Levothyroxine Sodium Tablets
Subpotent and Superpotent Drug
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