Edge Pharma recalls 2.5% Promethazine HCl topical ointment due to CGMP deviations. Affected units have specific NDC and batch numbers. Consumers should contact Edge for details.
CGMP Deviations
Edge Pharma is recalling a specific Promethazine HCl topical ointment product due to manufacturing quality control issues. This recall affects consumers who may have purchased the product with the listed NDC number and batch dates. The issue could lead to potential product safety concerns if the ointment is used as intended.
The recall is for CGMP (Current Good Manufacturing Practices) deviations, which means the product was made under conditions that don't meet the required quality standards. This could affect the safety and effectiveness of the ointment when used topically.
People who purchased the specific Promethazine HCl topical ointment with NDC 05446-1341-01 from Edge Pharma. Those using the product for topical application are most at risk due to the manufacturing deviations.
Check for the NDC number 05446-1341-01 on the product label. The product was sold between December 2021 and March 2022 with specific batch dates listed in the recall notice.
Look for the NDC number 05446-1341-01 on the ointment container.
The recall indicates potential manufacturing quality issues, but the official notice does not specify if the product is safe to use.
Check for the NDC number 05446-1341-01 on the product label. The product was sold between December 2021 and March 2022.
The recall notice does not specify a remedy, so contact Edge Pharma directly for further instructions.
We’ve drafted a message you can send Edge to request your refund or repair — edit it as you like.
Subject: Recall D-0446-2022 — Edge Edge Hello, I own a Edge that is covered by recall D-0446-2022 from Edge. 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.
