Sapropterin Dihydrochloride Powder for Oral Solution, 100 mg, 30 individual packets per carton, Rx Only, Dr. Reddy's, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, NDC: 43598-477-11 (packet), 43598-477-30 (carton).
Reported: March 2, 2022 Initiated: February 17, 2022 #D-0640-2022
Product Description
Sapropterin Dihydrochloride Powder for Oral Solution, 100 mg, 30 individual packets per carton, Rx Only, Dr. Reddy's, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, NDC: 43598-477-11 (packet), 43598-477-30 (carton).
Reason for Recall
Subpotent Drug: Out-of-specification results observed in Assay in sapropterin dihydrochloride powder 100mg.
Details
- Recalling Firm
- Dr. Reddy's Laboratories, Inc.
- Units Affected
- 340 packets
- Distribution
- Nationwide in the USA.
- Location
- Princeton, NJ
Frequently Asked Questions
What product was recalled? ▼
Sapropterin Dihydrochloride Powder for Oral Solution, 100 mg, 30 individual packets per carton, Rx Only, Dr. Reddy's, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, NDC: 43598-477-11 (packet), 43598-477-30 (carton).. Recalled by Dr. Reddy's Laboratories, Inc.. Units affected: 340 packets.
Why was this product recalled? ▼
Subpotent Drug: Out-of-specification results observed in Assay in sapropterin dihydrochloride powder 100mg.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on March 2, 2022. Severity: Low. Recall number: D-0640-2022.
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