Dr. Reddy's Laboratories, Inc. recalls Phytonadione Injectable Emulsion, USP, 10 mg/mL 1 mL ampule (NDC 43598-405-11) packaged in 25 x 1 mL Single-Dose Ampule…
- Recall date
- March 16, 2020
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- D-1094-2020
- FDA classification
- Class I
- Brand / firm
- Dr. Reddy's Laboratories, Inc.
- Sold / distributed
- Nationwide within the United States
Why it was recalled
Defective Container: Recall is due to breaking and shattering of ampules upon opening
Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.
What was recalled
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.
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