Class II · Moderate risk Terminated
Allopurinol Tablets, USP 300mg, 100 Tablets per bottle, Rx only, Manufactured By: Dr. Reddy's Laboratories LA LLC, Shreveport, LA…
Reason Presence of foreign substance.
ALLOPURINOL TABLETS, USP, 300 mg, 500 count bottle, Rx only, Manufactured for: QUALITEST…
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Failed Tablet/Capsule Specifications; report of oversized and discolored tablets
What was recalled
ALLOPURINOL TABLETS, USP, 300 mg, 500 count bottle, Rx only, Manufactured for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811 --- NDC 0603-2116-28
- Recalling firm
- Qualitest Pharmaceuticals
- NDC code
- 0603-2116-28
- Origin
- AL, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1405-2015
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Other Allopurinol recalls
See all
Class II · Moderate risk Terminated
Allopurinol Tablets 100mg, USP, 90-count bottles, Rx Only, 90, Mfg: Accord Healthcare, Inc; Durham, NC, PREFERRED…
Reason Presence of Foreign Substance: manufacturer recalled this re-packaged product due to reports of a small piece of green plastic embedded in the crack…
Class II · Moderate risk Terminated
Allopurinol Tablets USP, 100 mg, 100-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703…
Reason 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 Terminated
ALLOPURINOL Tablets, USP 300 MG 500 count Tablets per bottle, Rx only, Manufactured By: Dr. Reddy's Laboratories LA LLC…
Reason CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Class II · Moderate risk Terminated
Aloprim (allopurinol sodium) for Injection, 500 mg Single-Dose Vial, Rx only, Manufactured for: Mylan Institutional LLC…
Reason Discoloration: Out-of-specification results for appearance obtained during routine stability testing at the end of shelf-life for the parameters…
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