AVKARE LLC recalls 1 mg Glycopyrrolate tablets due to unspecified impurities. Consumers with Rx-only unit dose cartons from Pulaski, TN (NDC 50268-363-15) should check lot numbers 43313 or 43342.
Failed impurities/degradation specifications: Out of specification for unknown impurities.
AVKARE LLC is recalling 1 mg Glycopyr: 50-tablet unit dose cartons (Rx only) made in Pulaski, TN. The recall is due to unknown impurities that could affect safety. This is a medication recall for prescription use only.
The tablets failed quality tests for unknown impurities. These impurities could potentially affect the medication's safety, though the exact risk is not specified in the recall notice.
Prescription holders of the 1 mg Glycopyrrolate tablets in unit dose cartons from Pulaski, TN. People with the specific lot numbers 43313 or 43342 are most at risk.
Check for the unit dose carton labeled 'Glycopyrrolate Tablets, USP, 1 mg, 50 Tablets (5x10)' with NDC 50268-363-15. Look for lot numbers 43313 or 43342 from the manufacturing date in Pulaski, TN.
Identify the NDC number 50268-363-15 and lot numbers 43313 or 43342 on the unit dose carton.
The recall is due to failed impurities/degradation specifications, meaning unknown impurities were found that could affect safety.
Check the product details for NDC 50268-363-15 and lot numbers 43313 or 43342. If you have these, contact your pharmacy for guidance.
The recall notice does not specify a deadline for action.
We’ve drafted a message you can send AVKARE to request your refund or repair — edit it as you like.
Subject: Recall D-0091-2023 — AVKARE AVKARE Hello, I own a AVKARE that is covered by recall D-0091-2023 from AVKARE. 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.
