Tolmar recalls Eligard (leuprolide acetate) injections due to higher than expected leuprolide acetate levels in the reconstituted product. This may cause serious side effects. Affected units have NDC 62935-753-75 and lot 13635A1.
Superpotent Drug - Higher than expected levels of leuprolide acetate in the constituted product.
Tolmar is recalling Eligard injections because they contain higher than expected levels of leuprolide acetate after reconstitution. This could lead to serious side effects if used as directed. People with a prescription for this medication should check if they have the recalled batch.
The product contains higher than expected levels of leuprolide acetate after being reconstituted. This can cause serious side effects like severe pain, swelling, or other adverse reactions when injected.
People with a prescription for Eligard injections (7.5 mg monthly) are affected. Those who have the specific NDC 62935-753-75 and lot 13635A1 are at highest risk.
Check the product label for NDC 62935-753-75 and lot number 13635A1. Eligard is a prescription-only injectable medication that must be reconstituted before use.
Look for NDC 62935-753-75 and lot number 13635A1 on the product label.
The product may contain higher than expected levels of leuprolide acetate, which could cause serious side effects. Do not use until you confirm it's not recalled.
Check the product label for NDC 62935-753-75 and lot 13635A1. If you have these details, contact Tolmar for instructions.
The recall record does not specify a deadline for action.
We’ve drafted a message you can send Tolmar to request your refund or repair — edit it as you like.
Subject: Recall D-1178-2023 — Tolmar Tolmar Hello, I own a Tolmar that is covered by recall D-1178-2023 from Tolmar. 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.
