The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0415-2015·Announced 2015-03-25

Heritage Pharmaceuticals Recalls Colistimethate Sodium Injection Due to Sterility Concerns

Heritage Pharmaceuticals is recalling Colistimethate Sodium Injection due to quality control concerns regarding sterility assurance.

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 agency classification is FDA Class II. Per the rubric, FDA Class II recalls with potential for adverse health consequences (such as sterility issues in injectables) are classified as Severe (Score 4), as they are not Class I but involve significant risk.

Plain-English summary

Heritage Pharmaceuticals, Inc. is recalling Colistimethate Sodium for Injection USP, 150 mg per vial, due to concerns with quality control processes that affect the assurance of sterility. The product is a prescription-only injectable medication manufactured by Emcure Pharmaceuticals Ltd. in India for Heritage Pharmaceuticals Inc.

The recall covers specific lots of the product with expiration dates ranging from September 2014 to October 2016. The distribution pattern is listed as nationwide. The source text does not specify the number of units recalled or report any illnesses or injuries associated with the product.

Consumers and healthcare providers should stop using the affected lots and contact their healthcare provider or the recalling firm for further instructions. The recall is classified as FDA Class II, indicating a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product
COLISTIMETHATE SODIUM (COLISTIMETHATE SODIUM)
Brand
COLISTIMETHATE SODIUM
Manufacturer
Heritage Pharmaceuticals, Inc.
Category
Drug — Injectable
Hazard

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 (18)

  • Lot # VCOA002
  • Exp. 09/14
  • VCOA003
  • Exp. 10/14
  • VCOA004
  • Exp. 10/14 VCOA005
  • Exp. 01/15
  • VCOA006
  • Exp 03/15
  • VCOA007
  • Exp 09/15
  • VCOA008
  • Exp. 12/15
  • VCOA009
  • Exp. 02/16
  • VCOA010
  • Exp. 10/16 VCOA011
  • Exp. 10/16

UPCs (1)

  • 0323155193312

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 →

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