Heritage Pharmaceuticals Recalls Subpotent Etomidate Injection Vials
Heritage Pharmaceuticals is recalling 11,888 vials of Etomidate Injection because the drug was found to be subpotent. The recall is voluntary and nationwide.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, which indicates a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences. The hazard is a subpotent drug, which poses a risk of treatment failure but is not associated with reported deaths or serious injuries in the source text.
Plain-English summary
Heritage Pharmaceuticals, Inc. is voluntarily recalling 11,888 units of Etomidate Injection, USP 20 mg/10mL (2mg/mL) 10 mL Single-Dose Vials. The product is prescription-only and was manufactured in India. The recall was initiated on February 15, 2019, and the FDA classified it as Class II.
The reason for the recall is that the drug was found to be subpotent, meaning it contained less of the active ingredient than labeled. The affected lots are AMA701 (expiring March 2019), AMA702, and AMA703 (expiring August 2019). The product was distributed nationwide within the United States.
Healthcare providers and patients should check their inventory for the specific NDC 23155-160-31 and lot numbers listed above. If the product is found, it should be returned to the distributor or the recalling firm. The recall status is currently terminated.
The recalled product
- 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
- Manufacturer
- Heritage Pharmaceuticals, Inc.
- Category
- Drug — Injection
- Hazard
- Affected units
- 11,888
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- Lot #: AMA701
- Exp. March 2019
- AMA702
- AMA703
- Exp August 2019.
Distribution
Distributed nationwide across the United States.
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