Advanced Pharma Recalls Glycopyrrolate Syringes Due to Sterility Concerns
Advanced Pharma Inc. is recalling 2,580 syringes of Glycopyrrolate Injectable Solution nationwide due to a lack of assurance of sterility.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II and involves a risk-of-harm product (sterility issue) where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Advanced Pharma Inc. is recalling 2,580 syringes of Glycopyrrolate Injectable Solution 1 mg/5 mL (0.2 mg per mL), sterile single-use syringes. The recall is being conducted because of a lack of assurance of sterility. The affected product is identified by NDC 42852-828-67.
The recall covers three specific lots: 12/05/18 0710 82867S (Exp. 5/4/2019), 10/24/18 0014 82867S (Exp. 3/23/2019), and 11/01/18 8800 82867S (Exp. 3/31/2019). The product was distributed nationwide. The FDA has classified this recall as Class II.
Healthcare providers and patients should check their inventory for these specific lot numbers and stop using the product if it matches the recalled lots. For more information, contact Advanced Pharma Inc. at (877) 794-0404.
The recalled product
- Product
- Glycopyrrolate Injectable Solution 1 mg/5 mL (0.2 mg per mL), Sterile single use syringe, NDC: 42852-828-67 Avella of Houston 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404
- Manufacturer
- Advanced Pharma Inc.
- Category
- Drug — Injectable Solution
- Hazard
- Affected units
- 2,580
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 (3)
- Lot: 12/05/18 0710 82867S Exp. 5/4/2019
- 10/24/18 0014 82867S Exp. 3/23/2019
- 11/01/18 8800 82867S Exp. 3/31/2019
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 19 recalled by Advanced Pharma 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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