The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0997-2015·Announced 2015-05-20

Akorn Recalls Sulfamethoxazole and Trimethoprim Oral Suspension for Dissolution Failure

Akorn, Inc. is recalling 8,400 cups of Sulfamethoxazole and Trimethoprim oral suspension because the sulfamethoxazole failed to meet dissolution 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 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, which typically involves a situation that might cause temporary or medically reversible adverse health consequences. The hazard is a failure to meet dissolution specifications, which is a quality control issue rather than a direct safety hazard like contamination or mislabeling.

Plain-English summary

Akorn, Inc. is recalling 8,400 unit dose cups (20 mL each) of Sulfamethoxazole and Trimethoprim Oral Suspension, USP 800 mg/160 mg per 5mL, Grape Flavor. The product is identified by NDC 50383-0824-20, Lot # 624271, and an expiration date of 10/2015. The manufacturer is Hi-Tech Pharmacal Co. Inc., located in Amityville, NY.

The recall was initiated because the product failed to meet dissolution specifications for sulfamethoxazole. This means the active ingredient may not dissolve at the required rate, potentially affecting the medication's effectiveness.

The affected product was distributed nationwide and in Puerto Rico. Consumers and healthcare providers should stop using the recalled product and contact their pharmacist or physician for guidance on obtaining a replacement.

The recalled product

Product
SULFAMETHOXAZOLE AND TRIMETHOPRIM ORAL SUSPENSION, USP 800 mg/ 160 mg per 5mL, GRAPE FLAVOR, 20 mL unit dose cup (NDC 50383-0824-20), Rx only, HI-TECH PHARMACAL CO. INC, Amityville, NY 11701
Manufacturer
Akorn, Inc.
Category
Drug — Antibiotic
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 (2)

  • Lot # 624271
  • Exp. Date 10/2015

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 3 recalled by Akorn, 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 3 products in this recall →

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