D-0486-2024 Class I Ongoing
FDA drug recall D-0486-2024 was initiated by Dr. Reddy's Laboratories, Inc. on April 8, 2024 and is designated Class I. Reason for recall: Sub-potent Drug; powder discoloration associated with decreased potency The recall status is ongoing. Affected quantity: 2402 cartons.
Recall Details
- Product Type
- Drugs
- Report Date
- May 15, 2024
- Initiation Date
- April 8, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2402 cartons
Product Description
Sapropterin Dihydrochloride Powder for Oral Solution 100mg, 30 individual packets per carton, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, NDC 43598-477-30.
Reason for Recall
Sub-potent Drug; powder discoloration associated with decreased potency
Distribution Pattern
Nationwide in the USA
Code Information
Lot # T2200352, Exp. 12/31/2024