Amerisource Health Services recalls Tizanidine 4mg tablets due to failed dissolution specifications. This repackaged product may not dissolve properly as tested, potentially affecting medication effectiveness.
Failed Dissolution Specifications: this repackaged product was recalled by the manufacturer, Dr. Reddy's Laboratories, Inc., due to out of specification results for dissolution.
Amerisource Health Services is recalling Tizanidine 4mg tablets that were repackaged by Dr. Reddy's Laboratories. The product failed dissolution tests, meaning it may not dissolve properly in the body and could affect medication effectiveness.
The tablets failed dissolution specifications, meaning they may not dissolve properly in the body. This could lead to inconsistent medication effectiveness, but does not pose a direct safety risk like injury or death.
Prescription patients who received Tizanidine 4mg tablets with NDC 68084-645-01, lot 1004835, expiring July 31, 2023. Patients taking this medication for muscle spasms or other conditions are most at risk.
Look for Tizanidine 4mg tablets in 100-count blister packs with NDC 68084-645-01, lot 1004835, expiring July 31, 2023. The product was distributed by American Health Packaging in Columbus, Ohio.
Verify the NDC code 68084-645-01, lot number 1004835, and expiration date of July 31, 2023 on the packaging.
The product failed dissolution specifications, meaning it may not dissolve properly in the body and could affect medication effectiveness.
No, this recall is for potential medication effectiveness issues, not a safety hazard like injury or death.
Check for NDC 68084-645-01, lot 1004835, and expiration date of July 31, 2023 on the packaging.
We’ve drafted a message you can send Amerisource Health Services to request your refund or repair — edit it as you like.
Subject: Recall D-0892-2023 — Amerisource Health Services Amerisource Health Services Hello, I own a Amerisource Health Services that is covered by recall D-0892-2023 from Amerisource Health Services. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
