PD-Rx Pharmaceuticals recalls 10mg Montelukast Sodium 30-count bottles due to CGMP deviations. Affected lots expire through July 2024. Consumers should contact the manufacturer for details.
CGMP deviations.
PD-Rx Pharmaceuticals is recalling 10mg Montelukast Sodium 30-count bottles that were manufactured with CGMP deviations. This recall affects specific production lots that expire through July 2024. The issue means the medication may not meet quality standards, though no injuries have been reported.
CGMP deviations refer to failures in the manufacturing process that could affect the medication's quality. This means the product might not meet the required standards for safety and effectiveness, but no injuries have been reported.
Prescription medication users who have the specific lot numbers listed in the recall. People with asthma or allergies requiring montelukast may be most at risk.
Check the bottle for the lot numbers: L22C80, I22D93, K21C72 (expiring 11/30/23), A23A90, B23A09 (expiring 07/31/24), K22C33 (expiring 05/31/24), and others listed in the recall.
Look for lot numbers on the bottle: L22C80, I22D93, K21C72, A23A90, B23A09, K22C33, G22E88, G22F66, I22E27, C22B27, D22B94, E22C71, I21E36.
The recall is due to CGMP deviations, which means the manufacturing process did not meet quality standards.
Check the lot numbers on the bottle. If it matches the listed lots, contact PD-Rx Pharmaceuticals for instructions.
No injuries have been reported as of the recall announcement.
We’ve drafted a message you can send PD-Rx to request your refund or repair — edit it as you like.
Subject: Recall D-0557-2023 — PD-Rx PD-Rx Hello, I own a PD-Rx that is covered by recall D-0557-2023 from PD-Rx. 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.
