D-0640-2022 Class III Terminated
FDA drug recall D-0640-2022 was initiated by Dr. Reddy's Laboratories, Inc. on Feb 17, 2022 and is designated Class III. Reason for recall: Subpotent Drug: Out-of-specification results observed in Assay in sapropterin dihydrochloride powder 100mg. The recall status is terminated (terminated Jan 29, 2025). Affected quantity: 340 packets.
Recall Details
- Product Type
- Drugs
- Report Date
- Mar 2, 2022
- Initiation Date
- Feb 17, 2022
- Termination Date
- Jan 29, 2025
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 340 packets
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.
Distribution Pattern
Nationwide in the USA.
Code Information
T2100891, Exp. 02/28/2024
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0640-2022
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026