Moses Lake Pharmacy Recalls Methylcobalamin Syringes Due to Sterility Concerns
JD & SN Inc. is recalling methylcobalamin/hydroxocobalamin syringes because the company cannot ensure the products are sterile.
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, which corresponds to a 'Severe' rating under the rubric, particularly given the risk of infection associated with non-sterile injectable drugs.
Plain-English summary
JD & SN Inc., dba Moses Lake Professional Pharmacy, is recalling Methylcobalamin/Hydroxocobalamin Preservative Free Unit Dose Syringes. The recall is being conducted because the company lacks assurance of the sterility of the products. The affected items are injectable solutions in 20 mL syringes, available by prescription only.
The recall covers specific lots of the product, identified by the codes t09232014@24 and t03122015@11. The source text indicates that the recall applies to all sterile human compounded drugs within their expiry dates. The distribution pattern for these products is listed as nationwide.
Consumers and healthcare providers should stop using the recalled syringes immediately. Patients who have received these injections should contact their healthcare provider for guidance. The recalling firm is responsible for managing the recall and providing further information to affected parties.
The recalled product
- Product
- METHYLCOBALAMIN/HYDROXOCOBALAMIN PRESERVATIVE FREE UNIT DOSE SYRINGES, Injectable Solution, 2.5/0. 5MG/ML, 20 mL syringe, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314
- Category
- Drug — Injectable Solution
- Affected units
- 1
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)
- t09232014@24
- t03122015@11
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 101 recalled by JD & SN Inc., dba Moses Lake Professional 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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