The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0010-2016·Announced 2015-10-21

Nephron Recalls Ipratropium Bromide and Albuterol Sulfate Inhalation Solution

Nephron Pharmaceuticals is recalling Ipratropium Bromide and Albuterol Sulfate inhalation solution due to a lack of 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 recall is classified as FDA Class II, which corresponds to a Severe rating under the rubric, particularly given the risk of non-sterile contamination in an inhalation product.

Plain-English summary

Nephron Pharmaceuticals Corp. is recalling Ipratropium Bromide 0.5 mg and Albuterol Sulfate 3 mg Inhalation Solution. The affected product is packaged in 30x3 mL sterile unit-dose vials, available in 30-count and 60-count cartons. The recall covers Lot D4E20A and Lot D4C21A, both with an expiration date of 3/2016.

The recall was initiated due to a lack of assurance of sterility and the potential exposure to non-sterile lubricant during the filling process. The product was distributed nationwide. The total quantity recalled is 85,248 cartons of the 30-count package and 35,292 cartons of the 60-count package.

Consumers and healthcare providers should stop using the affected product and contact their pharmacist or healthcare provider for a replacement or refund. This is a prescription-only medication used for respiratory conditions.

The recalled product

Product
IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE (IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE)
Brand
IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE
Manufacturer
Nephron Pharmaceuticals Corp.
Category
Drug — Inhalation Solution
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 (3)

  • a) Lot D4E20A
  • exp 3/2016 and b) Lot D4C21A
  • exp 3/2016

UPCs (1)

  • 0304870201018

Distribution

Distributed nationwide across the United States.

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