Advanced Pharma Recalls Fentanyl Syringes Due to Incorrect Expiration Date
Advanced Pharma Inc. is recalling 100 syringes of Fentanyl in 0.9% Sodium Chloride due to an incorrect expiration date on the label.
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 and involves a minor labeling error (incorrect expiration date) without reported injuries or illnesses, fitting the 'Moderate' criteria for low-risk contamination or labeling issues.
Plain-English summary
Advanced Pharma Inc. is recalling 100 syringes of Fentanyl in 0.9% Sodium Chloride QS 0.5 mL, 5 mcg/0.5 mL with up to 0.1 mL of overfill Injectable Solution. The product is a sterile single-use syringe intended for prescription use only. The specific lot number is 12/31/18 0555 21072S, with an expiration date of 3/31/2019, and the NDC is 42852-210-72.
The recall was initiated because the product labeling contains an incorrect expiration date. This is a Class II recall, indicating a situation that might cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
The product was distributed in Pennsylvania. Healthcare providers and patients should stop using the affected syringes and contact Advanced Pharma Inc. at (877) 794-0404 for further instructions or to return the product.
The recalled product
- Product
- Fentanyl in 0.9% Sodium Chloride QS 0.5 mL, 5 mcg/0.5 mL with up to 0.1 mL of overfill Injectable Solution, Sterile single use syringe, Rx only, Avella of Houston 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404, NDC 42852-210-72
- Manufacturer
- Advanced Pharma Inc.
- Category
- Drug — Injectable Solution
- Hazard
- Affected units
- 100
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#: 12/31/18 0555 21072S
- Exp 3/31/2019
Distribution
Distributed in 1 state:
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