The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1868-2019·Announced 2019-09-25

Aurolife Pharma Recalls Fexofenadine Hydrochloride Tablets Due to Impurity Failures

Aurolife Pharma is recalling specific lots of Fexofenadine Hydrochloride 180 mg tablets because they failed impurity and degradation specifications.

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. Per the rubric, FDA Class II recalls with potential for adverse health consequences are rated as Severe (4).

Plain-English summary

Aurolife Pharma, LLC is recalling Fexofenadine Hydrochloride Tablets USP, 180 mg, in 30-count and 15-count cartons. The affected products are distributed by McKesson and are identified by specific lot numbers and expiration dates. The recall is being conducted because the tablets failed to meet impurities and degradation specifications.

The recall covers 11,928 cartons of the 30-count package (Lot 067180016B, Exp 05/21) and 288 cartons of the 15-count package (Lot 067180024F1, Exp 07/21). These products were distributed nationwide in the United States.

Consumers who have these specific products should stop using them and contact their healthcare provider or pharmacist for guidance. The recall is classified as FDA Class II, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.

The recalled product

Product
Fexofenadine Hydrochloride Tablets USP, 180 mg, packaged in a) 30-count carton (NDC 70677-0008-2) and b) 15-count carton (NDC 70677-0008-1), sunmark, Distributed by McKesson, One Post Street, San Francisco, CA 94104.
Manufacturer
Aurolife Pharma, LLC
Category
Drug — Prescription Medication
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)

  • Lot #s: a) 067180016B
  • Exp 05/21 and b) 067180024F1
  • Exp 07/21

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 11 recalled by Aurolife Pharma, LLC 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 11 products in this recall →

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