FDAClass IMay 15, 2024

Sapropterin Dihydrochloride Powder for Oral Solution recall

Sapropterin Dihydrochloride Powder for Oral Solution 100mg, 30 individual packets per carton, Rx Only, Distributor: Dr. Reddy's Laboratories Inc.…

Why was Sapropterin Dihydrochloride Powder for Oral Solution recalled?

Sub-potent Drug; powder discoloration associated with decreased potency

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot # T2200352, Exp. 12/31/2024

Product
Sapropterin Dihydrochloride Powder for Oral Solution 100mg, 30 individual packets per carton, Rx Only, Distributor: Dr. Reddy's Laboratories Inc.…
Recalling firm
Dr. Reddy's Laboratories, Inc.
Quantity
2402 cartons
Distribution
Nationwide in the USA
Recall date
May 15, 2024
Classification
Class I
Status
Ongoing
Agency
FDA (drug)
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