Methylcobalamin Injection Recalled for Lack of Sterility Assurance
First Pharma Associates is recalling Methylcobalamin 10 mg/mL Injection vials due to a lack of assurance of sterility. The product was distributed in Idaho and Washington.
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 recall is classified as FDA Class II and involves a lack of assurance of sterility in an injectable medication, which poses a significant risk of infection or serious injury.
Plain-English summary
First Pharma Associates LLC dba Riverpoint Pharmacy is recalling Methylcobalamin 10 mg/mL Injection, 5.4 mL vials, prescription only. The recall is being conducted due to a lack of assurance of sterility. The specific lot number is 06202019@29, with an expiration date of 08/19/2019.
The affected product was distributed only in Idaho and Washington. The recall is classified as Class II by the U.S. Food and Drug Administration. No specific illness or injury reports are mentioned in the source text.
Consumers and healthcare providers should stop using the recalled product and contact their pharmacist or the recalling firm for further instructions. The firm can be reached at (509) 343-6252 in Spokane, WA.
The recalled product
- Product
- Methylcobalamin 10 mg/mL Injection, 5.4 mL vial, Rx only, First Pharma Associates dba Riverpoint Pharmacy, Spokane, WA 99205, (509) 343-6252.
- Category
- Drug — Injectable Medication
- 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 #: 06202019@29
- Exp. 08/19/2019
Distribution
Part of a larger recall action
This product is one of 18 recalled by First Pharma Associates LLC dba Riverpoint Pharmacy 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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