Heritage Pharmaceuticals Recalls Amikacin Sulfate Injection Due to Microbial Growth
Heritage Pharmaceuticals is recalling Amikacin Sulfate Injection vials because microbial growth was detected in a sub-lot. The affected product is distributed nationwide in the USA.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The FDA has classified this recall as Class I, which meets the rubric criteria for a Critical severity score.
Plain-English summary
Heritage Pharmaceuticals, Inc. is recalling 14,960 vials of Amikacin Sulfate Injection, USP, 1 gram/4 mL (250 mg/mL). The recall is due to the detection of microbial growth in a sub-lot of the product. The affected lot number is VEAC025, with an expiration date of 10-2019.
The product is a prescription-only injection manufactured by Emcure Pharmaceuticals, Ltd. in India for Heritage Pharmaceuticals, Inc. It is distributed nationwide in the USA. The recall also notes that microbial growth was detected in a sub-lot of Prochlorperazine Edisylate Injection, USP, 10mg/2mL (5mg/mL).
Consumers and healthcare providers should stop using the affected product and contact their healthcare provider or the recalling firm for further instructions. The FDA has classified this recall as Class I, indicating a reasonable probability that use of the product may cause serious adverse health consequences or death.
The recalled product
- Product
- AMIKACIN SULFATE (AMIKACIN SULFATE)
- Brand
- AMIKACIN SULFATE
- Manufacturer
- Heritage Pharmaceuticals, Inc.
- Category
- Drug — Injection
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: VEAC025
- EXP 10-2019
UPCs (2)
- 0323155290325
- 0323155290318
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.
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