Why it was recalled
Subpotent Drug.
Product description
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
Lot numbers, UPCs & expiration codes
Lot #: AMA701, Exp. March 2019; AMA702, AMA703, Exp August 2019.
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-1065-2019
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Feb 15, 2019
- FDA report date
- Mar 27, 2019
- Quantity
- 11888 units
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Heritage Pharmaceuticals, Inc.
Original FDA data
Every field from FDA enforcement report D-1065-2019, exactly as published.
Show all FDA fields
- City
- East Brunswick
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 82198
- Address
- 1 Tower Center Blvd Ste 1700
- Code information
- Lot #: AMA701, Exp. March 2019; AMA702, AMA703, Exp August 2019.
- Postal code
- 08816-1145
- Report date
- Mar 27, 2019
- Product type
- Drugs
- Recall number
- D-1065-2019
- Classification
- Class II
- Recalling firm
- Heritage Pharmaceuticals, Inc.
- Product quantity
- 11888 units
- Termination date
- Mar 4, 2021
- Reason for recall
- Subpotent Drug.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- Nationwide within the United States
- Recall initiation date
- Feb 15, 2019
- Initial firm notification
- Letter
- Center classification date
- Mar 27, 2019