Heritage Pharmaceuticals Recalls Prochlorperazine Edisylate Injection Due to Microbial Growth
Heritage Pharmaceuticals is recalling Prochlorperazine Edisylate Injection because microbial growth was detected in a sublot. The affected vials are distributed nationwide.
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 source text explicitly states the agency classification is Class I, which mandates a severity score of 5 according to the rubric.
Plain-English summary
Heritage Pharmaceuticals, Inc. is recalling Prochlorperazine Edisylate Injection, USP 10 mg/2mL (5mg/mL), 2mL Vials. The recall is due to the detection of microbial growth in a sublot of the product. The specific lot number is VPCA172 with an expiration date of April 2020.
The affected product was manufactured by Emcure Pharmaceuticals Ltd. in India for Heritage Pharmaceuticals Inc. and is distributed nationwide in the USA. The recall involves 55,480 2 mL vials. The agency has classified this recall as Class I.
Consumers and healthcare providers should stop using the affected product and contact their healthcare provider or the recalling firm for further instructions. Do not use the product if it is from the specified lot.
The recalled product
- Product
- PROCHLORPERAZINE EDISYLATE (PROCHLORPERAZINE EDISYLATE)
- Brand
- PROCHLORPERAZINE EDISYLATE
- 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: VPCA172
- EXP April 2020
UPCs (1)
- 0323155294316
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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