Agency classClass IIOur severity:Severe FDA (Drugs)·D-0416-2015·Announced 2015-03-25

Heritage Pharmaceuticals Recalls RIFAMPIN for Injection Due to Sterility Concerns

Heritage Pharmaceuticals is recalling RIFAMPIN for Injection, USP, 600 mg per vial, due to quality control concerns regarding the assurance of sterility.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The FDA classified this recall as Class II. According to the rubric, an FDA Class II recall involving a sterile injectable product where sterility assurance is compromised is categorized as Severe (Score 4), as it carries a risk of serious adverse health consequences such as infection.

Plain-English summary

Heritage Pharmaceuticals, Inc. is recalling RIFAMPIN for Injection, USP, 600 mg per vial, Rx Only. The product is manufactured by Emcure Pharmaceuticals Ltd. in India and distributed nationwide. The recall involves 24,344 vials from three specific lots: VRIA002 (Exp. 08/16), VRIA003 (Exp. 09/16), and VRIA004 (Exp. 09/16).

The recall was initiated due to a lack of assurance of sterility, stemming from concerns with the firm's quality control processes. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

Healthcare providers and patients should stop using the affected lots of RIFAMPIN for Injection. Consumers and healthcare facilities should check their inventory for the specific lot numbers and expiration dates listed above and contact Heritage Pharmaceuticals for further instructions on how to return or dispose of the product.

The recalled product

Product: RIFAMPIN for Injection,USP, 600 mg per vial, Rx Only, Manufactured by: Emcure Pharmaceuticals Ltd., Hinjwadi, Pune, India Manufactured for: Heritage Pharmaceuticals Inc., Eatontown, NJ 07724 NDC 23155-340-31
Manufacturer: Heritage Pharmaceuticals, Inc.
Category: Drug — Injectable
Hazard: sterility
infection-risk
Affected units: 24,344

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 # VRIA002
Exp. 08/16
VRIA003
Exp. 09/16
VRIA004

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by Heritage Pharmaceuticals, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Same manufacturer · Heritage Pharmaceuticals, Inc.

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Same hazard · sterility