Recalls / Class II
Class IID-1065-2019
Product
Etomidate Injection, USP 20 mg/10mL (2mg/mL) 10 mL Single-Dose Vial, Rx only, Manufactured for: Heritage Pharmaceuticals Inc. Made in India, NDC 23155-160-31
- Affected lot / code info
- Lot #: AMA701, Exp. March 2019; AMA702, AMA703, Exp August 2019.
Why it was recalled
Subpotent Drug.
Recalling firm
- Firm
- Heritage Pharmaceuticals, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1 Tower Center Blvd Ste 1700, N/A, East Brunswick, New Jersey 08816-1145
Distribution
- Quantity
- 11888 units
- Distribution pattern
- Nationwide within the United States
Timeline
- Recall initiated
- 2019-02-15
- FDA classified
- 2019-03-27
- Posted by FDA
- 2019-03-27
- Terminated
- 2021-03-04
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1065-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.