The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0385-2015·Announced 2015-02-18

Akorn Recalls Erythromycin Pledgets Due to Microbial Contamination

Akorn, Inc. is recalling Erythromycin Pledgets USP, 2%, 60-count jars because the active pharmaceutical ingredient failed USP microbial tests.

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 microbial contamination in a pharmaceutical product.

Plain-English summary

Akorn, Inc. is recalling Erythromycin Pledgets USP, 2%, 60-count jars, which are prescription-only products. The recall was initiated because the active pharmaceutical ingredient (API) failed USP microbial tests, indicating microbial contamination of the non-sterile product.

The affected product is manufactured by Ei LLC in Kannapolis, NC, and marketed by VersaPharm Incorporated in Marietta, GA. The specific NDC number is 61748-202-60. A total of 23,449 jars are involved in this recall, which has a nationwide distribution pattern.

The affected lots include Lot # 1446800 (Exp. 03/15), Lot # 1538100 (Exp. 05/15), Lot # 1538101 (Exp. 05/15), Lot # 1538200 (Exp. 06/15), and Lot # 1608200 (Exp. 08/15). Consumers and healthcare providers should check their inventory for these specific lot numbers and expiration dates. If the product matches the recalled description, it should be returned to the pharmacy or supplier for a refund or replacement, or disposed of according to local regulations.

The recalled product

Product
Erythromycin Pledgets USP, 2%, 60-count jar,Rx only, Manufactured by Ei LLC, Kannapolis, NC 28083, Marketed by VersaPharm Incorporated, Marietta, GA 30062, NDC 61748-202-60 .
Manufacturer
Akorn, Inc.
Category
Drug — Antibiotic
Hazard
Affected units
23,449

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 (6)

  • Lot # 1446800
  • Exp. 03/15 Lot # 1538100
  • Exp. 05/15 Lot # 1538101
  • Exp. 05/15 Lot # 1538200
  • Exp. 06/15 Lot # 1608200
  • Exp. 08/15

Distribution

Distributed nationwide across the United States.

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