Why it was recalled
Failed Stability Specifications: Out of specification results reported at 12-month stability testing for aluminum content.
Product description
Phytonadione Injectable Emulsion USP, 10 mg/mL, 25x 1 mL single dose ampules per carton, Rx only, Distributed by: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, NDC 43598-405-16
Lot numbers, UPCs & expiration codes
Lot # ACB101, Exp 03/2023
Where it was sold
USA nationwide
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-0007-2023
- Classification
- Class III
- Status
- Completed
- Recall initiated
- Sep 14, 2022
- FDA report date
- Oct 12, 2022
- Quantity
- 2,838 ampules
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Dr. Reddy's Laboratories, Inc.
Original FDA data
Every field from FDA enforcement report D-0007-2023, exactly as published.
Show all FDA fields
- City
- Princeton
- State
- NJ
- Status
- Completed
- Country
- United States
- Event ID
- 90868
- Address
- 107 College Rd E
- Code information
- Lot # ACB101, Exp 03/2023
- Postal code
- 08540-6623
- Report date
- Oct 12, 2022
- Product type
- Drugs
- Recall number
- D-0007-2023
- Classification
- Class III
- Recalling firm
- Dr. Reddy's Laboratories, Inc.
- Product quantity
- 2,838 ampules
- Reason for recall
- Failed Stability Specifications: Out of specification results reported at 12-month stability testing for aluminum content.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Phytonadione Injectable Emulsion USP, 10 mg/mL, 25x 1 mL single dose ampules per carton, Rx only, Distributed by: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, NDC 43598-405-16
- Distribution pattern
- USA nationwide
- Recall initiation date
- Sep 14, 2022
- Initial firm notification
- Letter
- Center classification date
- Oct 6, 2022