Class III
Terminated
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).
- Company
- Dr. Reddy'S Laboratories, Inc.
- Recall Initiated
- February 17, 2022
- Posted
- March 2, 2022
- Recall Number
- D-0640-2022
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 340 packets
- Firm Location
- Princeton, NJ, United States
Reason for Recall
Subpotent Drug: Out-of-specification results observed in Assay in sapropterin dihydrochloride powder 100mg.
Distribution
Nationwide in the USA.
Lot / Code Info
T2100891, Exp. 02/28/2024
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