MedPark Pharmacy Recalls Methylcobalamin Injection Vials Due to Sterility Concerns
MedPark Pharmacy is recalling methylcobalamin 1mg/1mL injection vials because the company cannot ensure the product is sterile. The affected lot was distributed to a patient in Maryland.
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 classification is FDA Class II. Per the rubric, FDA Class II recalls are assigned a score of 4 (Severe), particularly when involving potential serious health consequences such as sterility failures in injectable drugs.
Plain-English summary
MedPark Pharmacy, LLC is recalling methylcobalamin 1mg/1mL vials for injection. The recall was initiated because the company lacks assurance of the sterility of the product. The specific lot number is 20170323-01, and the expiration date is 09/18/2017.
The affected product was distributed to a patient in Maryland. The FDA has classified this recall as Class II, which means the use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
Consumers who have this product should stop using it and contact their healthcare provider or MedPark Pharmacy for instructions on how to return or dispose of the medication.
The recalled product
- Product
- methylcobalamin 1mg/1mL, vial for injection, Rx only, MedPark Pharmacy 2002 Medical Pkwy. # 170 Annapolis, MD 21401
- Manufacturer
- MedPark Pharmacy, LLC
- Category
- Drug — Injectable
- Hazard
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 #: 20170323-01
- Exp.09/18/2017
Distribution
Distributed in 1 state:
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