Class II · Moderate risk
Allopurinol Tablets
Presence of foreign substance.
Allopurinol Tablets 100mg
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
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.
Cause type: Particulate / foreign matter
Visible foreign particles - glass, metal, fibers or other material - found in the product. Particles can enter from equipment wear, containers or the process, and are dangerous in injectables. All particulate / foreign matter recalls.
What was recalled
Allopurinol Tablets 100mg, USP, 90-count bottles, Rx Only, 90, Mfg: Accord Healthcare, Inc; Durham, NC, PREFERRED Pharmaceuticals, Inc., The Physician's Solution, Prod#: 68788-7383-09.
Affected NDC
68788-7383-09
Compare with the code on your package — it is the most precise check available.
Drug: Allopurinol
- Recalling firm
- Preferred Pharmaceuticals, Inc.
- Origin
- CA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0173-2023 · 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 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 II · Moderate risk
Aloprim (allopurinol sodium)
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.
Class III · Low risk
Allopurinol Tablets
Failed Tablet/Capsule Specifications; report of oversized and discolored tablets
Other recalls by Preferred Pharmaceuticals, Inc.
All 2023 recalls
Class II · Moderate risk
Artificial Tears Lubricant Eye Drops
Lack of Assurance of Sterility
Class II · Moderate risk
Ondansetron ODT Tablets
Defective container: Preferred Pharmaceuticals received a letter from the manufacturer Glenmark, that the blister packs are not fully sealed and tablets falling out. Preferred Pharmaceuticals purchased the finished product and repackaged the product for sale.
Class II · Moderate risk
Clindamycin Hydrochloride Capsules
cGMP Deviations
Class II · Moderate risk
Ibuprofen Tablets
Failed Impurities/Degradation Specifications - at 18-month Stability testing
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