API Solutions recalls Estriol USP41 Micro 25g due to cGMP deviations. Learn if you have affected units and what to do.
cGMP Deviations
API Solutions is recalling Estriol USP41 Micro 25g products because of manufacturing quality control issues. This recall affects products distributed by Syntec and sold with specific lot numbers. The issue could lead to unsafe drug quality, but no injuries have been reported.
The product was manufactured without following current Good Manufacturing Practices (cGMP), which are strict quality standards for drugs. This could result in unsafe drug quality, but the exact risk level isn't specified in the recall notice.
People who purchased Estriol USP41 Micro 25g from Syntec or other distributors in the US. Those using this hormone replacement therapy product are most at risk.
Check for the lot number ETL181001 and expiration date 10/09/2021 on the product label. The product is sold under NDC 46144-300-01 and distributed by Syntec.
Look for the lot number ETL181001 and expiration date 10/09/2021 on the product label.
The recall states there were cGMP deviations, but no injuries have been reported. The product may not be safe due to manufacturing issues.
Check for the lot number ETL181001 and expiration date 10/09/2021 on the product label. The product is sold under NDC 46144-300-01 and distributed by Syntec.
The recall does not specify a remedy, so no action is required beyond checking if you have the product.
We’ve drafted a message you can send API Solutions to request your refund or repair — edit it as you like.
Subject: Recall D-0695-2021 — API Solutions API Solutions Hello, I own a API Solutions that is covered by recall D-0695-2021 from API Solutions. 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.
