Dr. Reddy's recalls 100mg Sapropterin Dihydrochloride Powder for Oral Solution due to potential decreased potency from discoloration. Affected units have specific lot numbers and expiration dates.
Sub-potent Drug; powder discoloration associated with decreased potency
Dr. Reddy's is recalling Sapropterin Dihydrochloride Powder for Oral Solution 100mg because the powder may discolor and lose potency. This could affect the drug's effectiveness for patients using it under a prescription.
The powder may discolor and become less potent, meaning it might not work as intended for patients. This is a quality issue that could affect the drug's effectiveness but does not pose an immediate safety risk.
Prescription patients using Sapropterin Dihydrochloride Powder for Oral Solution 100mg. Those with the specific lot number T2200352 are most at risk.
Check for the product name 'Sapropterin Dihydrochloride Powder for Oral Solution 100mg', 30 packets per carton, and lot number T2200352. The expiration date is December 31, 2024.
Identify the lot number and expiration date on the packaging to confirm if it matches T2200352 and December 31, 2024.
The powder may discolor and become less potent, which could affect its effectiveness for patients using it under a prescription.
The recall does not specify a remedy, so check the product details to see if it matches the affected lot number and expiration date.
No, the hazard is about decreased potency, not physical harm or injury.
We’ve drafted a message you can send Dr. Reddy's to request your refund or repair — edit it as you like.
Subject: Recall D-0486-2024 — Dr. Reddy's Dr. Reddy's Hello, I own a Dr. Reddy's that is covered by recall D-0486-2024 from Dr. Reddy's. 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.
