Ascend Laboratories recalls 20mg Aripiprazole tablets (NDC 67877-434-05) manufactured by Alkem Labs in India. The tablets failed a spectroscopic identification test, potentially affecting drug quality.
Out of specification (OOS) for Spectroscopic Identification test by IR.
Ascend Laboratories is recalling 20mg Aripiprazole tablets sold in 500-count bottles. The tablets failed a spectroscopic identification test, which could mean the medication isn't properly identified or may not be effective.
The tablets failed a spectroscopic identification test, meaning the medication might not be correctly identified or could be ineffective. This could lead to improper treatment if the medication doesn't work as intended.
People who have the 20mg Aripiprazole tablets (NDC 67877-434-05) packaged in 500-count bottles from Alkem Laboratories Ltd. in India. Those using prescription medication for mental health conditions are most at risk.
Check for the 20mg Aripiprazole tablets in 500-count bottles with NDC number 67877-434-05. The lot number is 22143120, and the expiration date is June 2024.
Look for the NDC number 67877-434-05 on the bottle label to confirm the recalled product.
The tablets failed a spectroscopic identification test, which could mean the medication isn't properly identified or may not be effective.
The recall record does not specify a remedy, so no action is required beyond checking if you have the product.
The recall record does not indicate if the product is safe; it only states the test failure.
We’ve drafted a message you can send Ascend Laboratories to request your refund or repair — edit it as you like.
Subject: Recall D-0539-2023 — Ascend Laboratories Ascend Laboratories Hello, I own a Ascend Laboratories that is covered by recall D-0539-2023 from Ascend 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.
