Drug Enforcement D-0007-2023

Failed Stability Specifications: Out of specification results reported at 12-month stability testing for aluminum content.

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Status

Completed

Classification

Class III

Report Date

October 12, 2022

Termination Date

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Product Information

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
Product quantity
2,838 ampules
Reason for recall
Failed Stability Specifications: Out of specification results reported at 12-month stability testing for aluminum content.
Recall initiation reason
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Initial firm notification
Letter
Distribution pattern
USA nationwide

Location & Firm

Recalling firm
Dr. Reddy's Laboratories, Inc.
Address
107 College Rd E, N/A

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
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Codes & Dates

Recall number
D-0007-2023
Event ID
90868
Recall initiation date
September 14, 2022
Center classification date
October 6, 2022
Code info
Lot # ACB101, Exp 03/2023
More code info
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