Why it was recalled
Defective Container: Recall is due to breaking and shattering of ampules upon opening
Product description
Phytonadione Injectable Emulsion, USP, 10 mg/mL 1 mL ampule (NDC 43598-405-11) packaged in 25 x 1 mL Single-Dose Ampules per carton (NDC 43598-405-16); Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540.
Lot numbers, UPCs & expiration codes
Lot #: ACB902, ACB903, Exp. Date 03/2021; ACB904, Exp. Date 04/2021, ACB905, Exp. Date 06/2021
Where it was sold
Nationwide within the United States
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-1094-2020
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Mar 16, 2020
- FDA report date
- Apr 8, 2020
- Quantity
- 10943 cartons
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Dr. Reddy's Laboratories, Inc.
Original FDA data
Every field from FDA enforcement report D-1094-2020, exactly as published.
Show all FDA fields
- City
- Princeton
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 85231
- Address
- 107 College Rd E
- Code information
- Lot #: ACB902, ACB903, Exp. Date 03/2021; ACB904, Exp. Date 04/2021, ACB905, Exp. Date 06/2021
- Postal code
- 08540-6623
- Report date
- Apr 8, 2020
- Product type
- Drugs
- Recall number
- D-1094-2020
- Classification
- Class I
- Recalling firm
- Dr. Reddy's Laboratories, Inc.
- Product quantity
- 10943 cartons
- Termination date
- Dec 22, 2022
- Reason for recall
- Defective Container: Recall is due to breaking and shattering of ampules upon opening
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Phytonadione Injectable Emulsion, USP, 10 mg/mL 1 mL ampule (NDC 43598-405-11) packaged in 25 x 1 mL Single-Dose Ampules per carton (NDC 43598-405-16); Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540.
- Distribution pattern
- Nationwide within the United States
- Recall initiation date
- Mar 16, 2020
- Initial firm notification
- Letter
- Center classification date
- Apr 6, 2020