Recalls / Class I
Class ID-1094-2020
Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences or death.
Product
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.
- Brand name
- Phytonadione
- Generic name
- Phytonadione
- Active ingredient
- Phytonadione
- Route
- Intramuscular, Intravenous, Subcutaneous
- NDC
- 43598-405
- FDA application
- ANDA207719
- Affected lot / code info
- Lot #: ACB902, ACB903, Exp. Date 03/2021; ACB904, Exp. Date 04/2021, ACB905, Exp. Date 06/2021
Why it was recalled
Defective Container: Recall is due to breaking and shattering of ampules upon opening
Recalling firm
- Firm
- Dr. Reddy's Laboratories, Inc.
- Manufacturer
- Dr.Reddy's Laboratories Inc
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 107 College Rd E, N/A, Princeton, New Jersey 08540-6623
Distribution
- Quantity
- 10943 cartons
- Distribution pattern
- Nationwide within the United States
Timeline
- Recall initiated
- 2020-03-16
- FDA classified
- 2020-04-06
- Posted by FDA
- 2020-04-08
- Terminated
- 2022-12-22
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1094-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.