FDAClass IIIMarch 2, 2022

Sapropterin Dihydrochloride Powder for Oral Solution recall: Subpotent

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

Why was Sapropterin Dihydrochloride Powder for Oral Solution recalled?

Subpotent Drug: Out-of-specification results observed in Assay in sapropterin dihydrochloride powder 100mg.

What should I do if I have this product?

Review the official FDA enforcement record for current 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?

T2100891, Exp. 02/28/2024

Product
Sapropterin Dihydrochloride Powder for Oral Solution, 100 mg, 30 individual packets per carton, Rx Only, Dr. Reddy's, Distributor: Dr. Reddy's…
Recalling firm
Dr. Reddy's Laboratories, Inc.
Quantity
340 packets
Distribution
Nationwide in the USA.
Recall date
March 2, 2022
Classification
Class III
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls