FDA Recalls Hydroxocobalamin Injectable Solution Due to Sterility Concerns
JD & SN Inc. is recalling Hydroxocobalamin Injectable Solution because the agency cannot ensure the product is sterile. Patients should stop using the product and contact their healthcare provider.
What this means for you
Illness, injury, or structural failure has been reported. 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 drug, which poses a risk of serious adverse health consequences such as infection, meeting the criteria for a Severe rating.
Plain-English summary
The U.S. Food and Drug Administration (FDA) has issued a recall for Hydroxocobalamin Multidose Vial, Injectable Solution, 5 mg/mL, manufactured by JD & SN Inc., dba Moses Lake Professional Pharmacy. The recall is being conducted because the agency cannot assure the sterility of the product. The affected product is a prescription-only injectable solution available in 6 mL, 10 mL, and 30 mL syringe sizes.
The recall covers specific lots of the product, including those with codes t12232014@26, t10302014@14, t09232014@18, t09052014@20, t08132014@15, t07222014@23, t06302015@24, and t03192015@37. The distribution pattern for these products is listed as nationwide. The recall is classified as Class II by the FDA, indicating a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
Patients and healthcare providers who have received or used this product should stop using it immediately. Consumers should contact their healthcare provider for further instructions and to determine if alternative treatment is necessary. The recalling firm is JD & SN Inc., dba Moses Lake Professional Pharmacy, located in Moses Lake, Washington.
The recalled product
- Product
- HYDROXOCOBALAMIN MULTIDOSE VIAL, Injectable Solution, 5 mg/mL, syringe sizes: 6 mL, 10 mL, 30 mL, 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
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 (8)
- t12232014@26
- t10302014@14
- t09232014@18
- t09052014@20
- t08132014@15
- t07222014@23
- t06302015@24
- t03192015@37.
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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