Why it was recalled
Subpotent Drug: Out-of-specification results observed in Assay in sapropterin dihydrochloride powder 100mg.
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).
Lot numbers, UPCs & expiration codes
T2100891, Exp. 02/28/2024
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-0640-2022
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Feb 17, 2022
- FDA report date
- Mar 2, 2022
- Quantity
- 340 packets
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Dr. Reddy's Laboratories, Inc.
Original FDA data
Every field from FDA enforcement report D-0640-2022, exactly as published.
Show all FDA fields
- City
- Princeton
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 89626
- Address
- 107 College Rd E
- Code information
- T2100891, Exp. 02/28/2024
- Postal code
- 08540-6623
- Report date
- Mar 2, 2022
- Product type
- Drugs
- Recall number
- D-0640-2022
- Classification
- Class III
- Recalling firm
- Dr. Reddy's Laboratories, Inc.
- Product quantity
- 340 packets
- Termination date
- Jan 29, 2025
- Reason for recall
- Subpotent Drug: Out-of-specification results observed in Assay in sapropterin dihydrochloride powder 100mg.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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).
- Distribution pattern
- Nationwide in the USA.
- Recall initiation date
- Feb 17, 2022
- Initial firm notification
- Letter
- Center classification date
- Feb 28, 2022