Pharmakon Recalls Glycopyrrolate Syringes for Undeclared Benzyl Alcohol
Pharmakon Pharmaceuticals is recalling 200 pre-filled syringes of Glycopyrrolate 0.2 mg/ml because they contain undeclared benzyl alcohol.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this as an FDA Class II recall. Per the rubric, FDA Class II recalls are assigned a score of 4 (Severe), particularly when involving undeclared excipients that may cause adverse health consequences.
Plain-English summary
Pharmakon Pharmaceuticals is recalling 200 pre-filled syringes of Glycopyrrolate 0.2 mg/ml, 5 mL, Rx Only. The product is identified by NDC 45183-0965-70, Lot E131210.212, and an expiration date of 07/14/2014.
The recall was initiated because the product contains undeclared benzyl alcohol. This is a Class II recall, indicating a situation that may cause temporary or medically reversible adverse health consequences.
The affected product was distributed in Texas, Illinois, Maryland, and Indiana. Patients and healthcare providers should stop using the recalled syringes and contact their pharmacist or physician for guidance on alternative treatment options.
The recalled product
- Product
- Glycopyrrolate 0.2 mg/ml, 5 mL pre-filled syringe, Rx Only. Pharmakon Pharmaceuticals, Inc., 14450 Getz Rd., Noblesville, IN 46060, NDC#: 45183-0965-70.
- Manufacturer
- Pharmakon Pharmaceuticals
- Category
- Drug — Injectable
- Affected units
- 200
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 (1)
- Lot #: E131210.212 Exp: 07/14/2014
Distribution
Part of a larger recall action
This product is one of 4 recalled by Pharmakon Pharmaceuticals 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.
See all 4 products in this recall →Related recalls
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