Unique Pharmaceutical Recalls N-Acetyl Cysteine Vials Due to Non-Sterility
Unique Pharmaceutical, Ltd is recalling one lot of N-Acetyl Cysteine 20% vials because testing revealed the presence of Herbaspirillum huttiense bacteria.
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 metadata explicitly identifies this as an FDA Class I recall, which corresponds to a Critical severity score (5) according to the rubric.
Plain-English summary
Unique Pharmaceutical, Ltd is recalling 3,529 vials of N-Acetyl Cysteine 20% 4 mL Vials (Stock Code: 4133). The recall involves Lot #86513, which has an expiration date of 07/23/2014. The product was distributed nationwide.
The recall was initiated because the specific lot tested positive for Herbaspirillum huttiense, indicating a non-sterility issue. This bacterial contamination poses a risk of infection to patients who receive the medication.
Consumers and healthcare providers should stop using the affected vials immediately. Those who have already used the product should contact their healthcare provider for medical advice. The recalling firm is responsible for managing the recall and removing the product from the market.
The recalled product
- Product
- N-Acetyl Cysteine 20% 4 mL Vial Stock Code: 4133
- Manufacturer
- Unique Pharmaceutical, Ltd
- Category
- Drug — Injectable Medication
- Affected units
- 3,529
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 #: 86513
- Exp 07/23/2014
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Unique Pharmaceutical, Ltd 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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