Homeocare Laboratories recalls Bebelyn Colic Drops due to cGMP deviations. Affected bottles have NDC 55758-036-01, Lot #2414, expiring Sep-24. Consumers should contact the manufacturer for details.
cGMP deviations
Homeocare Laboratories is recalling Bebelyn Colic Drops bottles that were manufactured with cGMP deviations. This means the product may not meet quality standards and could be unsafe for use.
cGMP deviations refer to failures in manufacturing quality control processes. This could result in the product not meeting safety and purity standards, potentially causing harm if used improperly.
Parents or caregivers who purchased Bebelyn Colic Drops bottles with NDC 55758-036-01, Lot #2414, expiring September 2024 are likely affected. Infants using the product are at higher risk due to potential quality issues.
Check for the NDC code 55758-036-01 and Lot #2414 on the bottle. The product expires September 2024. This recall applies to bottles distributed by Pharmadel LLC in Georgetown, DE.
Look for the NDC code 55758-036-01 and Lot #2414 on the bottle label.
The recall indicates cGMP deviations, which may affect product quality. Homeocare Laboratories has not specified if the product is safe to use.
The recall record does not mention a replacement or remedy for the product.
The recall record does not specify a remedy, so contact Homeocare Laboratories for further instructions.
We’ve drafted a message you can send Homeocare Laboratories to request your refund or repair — edit it as you like.
Subject: Recall D-0882-2023 — Homeocare Laboratories Homeocare Laboratories Hello, I own a Homeocare Laboratories that is covered by recall D-0882-2023 from Homeocare Laboratories. 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.
