Recalls / Class III
Class IIID-0640-2022
Product
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).
- Affected lot / code info
- T2100891, Exp. 02/28/2024
Why it was recalled
Subpotent Drug: Out-of-specification results observed in Assay in sapropterin dihydrochloride powder 100mg.
Recalling firm
- Firm
- Dr. Reddy's Laboratories, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 107 College Rd E, Princeton, New Jersey 08540-6623
Distribution
- Quantity
- 340 packets
- Distribution pattern
- Nationwide in the USA.
Timeline
- Recall initiated
- 2022-02-17
- FDA classified
- 2022-02-28
- Posted by FDA
- 2022-03-02
- Terminated
- 2025-01-29
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0640-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.