Why it was recalled
Sub-potent Drug; powder discoloration associated with decreased potency
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.
Lot numbers, UPCs & expiration codes
Lot # T2200352, Exp. 12/31/2024
Where it was sold
Nationwide in the USA
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0486-2024
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- Apr 8, 2024
- FDA report date
- May 15, 2024
- Quantity
- 2402 cartons
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Dr. Reddy's Laboratories, Inc.
Original FDA data
Every field from FDA enforcement report D-0486-2024, exactly as published.
Show all FDA fields
- City
- Princeton
- State
- NJ
- Status
- Ongoing
- Country
- United States
- Event ID
- 94369
- Address
- 107 College Rd E
- Code information
- Lot # T2200352, Exp. 12/31/2024
- Postal code
- 08540-6623
- Report date
- May 15, 2024
- Product type
- Drugs
- Recall number
- D-0486-2024
- Classification
- Class I
- Recalling firm
- Dr. Reddy's Laboratories, Inc.
- Product quantity
- 2402 cartons
- Reason for recall
- Sub-potent Drug; powder discoloration associated with decreased potency
- Voluntary / mandated
- Voluntary: Firm initiated
- 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.
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Apr 8, 2024
- Initial firm notification
- Letter
- Center classification date
- May 6, 2024