Blossom Pharmaceuticals recalls Nivagen Zinc Oxide Ointment USP 20% for cGMP deviations. Affected lots include A352505, made in India. Consumers should contact for details.
cGMP deviations
Blossom Pharmaceuticals is recalling Nivagen Zinc Oxide Ointment USP 20% due to cGMP deviations. This means the product may not meet quality standards, though the specific risk isn't detailed in the recall.
The recall is for cGMP deviations, which means the product may not meet quality standards. However, the specific hazard mechanism isn't described in the recall notice, so the risk level is unclear.
People who own or use the recalled Nivagen Zinc Oxide Ointment USP 20% (1 oz.) made in India with lot number A352505 are affected. The recall targets consumers using this specific product.
Check for the product name 'Nivagen Zinc Oxide Ointment USP 20%', net weight 1 oz. (28.4g), and lot number A352505. The product was made in India and distributed by Nivagen Pharmaceuticals, Inc. in Sacramento, CA.
Reach out to Blossom Pharmaceuticals for specific instructions on handling the recalled product.
The recall states cGMP deviations, but the specific risk isn't detailed. The official notice doesn't say if it causes injury or harm.
The recall doesn't specify a remedy, so contact Blossom Pharmaceuticals for instructions.
Check for the product name 'Nivagen Zinc Oxide Ointment USP 20%', net weight 1 oz. (28.4g), and lot number A352505.
We’ve drafted a message you can send Nivagen to request your refund or repair — edit it as you like.
Subject: Recall D-0209-2026 — Nivagen Nivagen Hello, I own a Nivagen that is covered by recall D-0209-2026 from Nivagen. 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.
