Partell Specialty Pharmacy Recalls Methionine Inositol Choline B12 Vials
Partell Specialty Pharmacy is recalling specific vials of a methionine, inositol, choline, and B12 combination drug due to a non-approved sterilization method.
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 drug products.
Plain-English summary
Partell Specialty Pharmacy is recalling specific vials of a prescription drug product containing Methionine 25mg, Inositol 50mg, Choline 50mg, and B12 1mg. The recall is being conducted because the firm used a non-approved method of sterilization for these products.
The affected product is a 50 mL amber vial, prescription only, manufactured by Partell Specialty Pharmacy in Las Vegas, Nevada. The specific lot number is 20180123@4, with a beyond-use date of 4/14/2018. The distribution was limited to Nevada.
Consumers and healthcare providers should check their inventory for this specific lot number and date. If found, the product should be returned to the pharmacy or disposed of according to local regulations. Patients should contact their healthcare provider for alternative treatment options if necessary.
The recalled product
- Product
- Methionine 25mg/Inositol 50mg/Choline 50mg/ B12 1mg, 50 mL amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800
- Manufacturer
- Partell Specialty Pharmacy
- Category
- Drug — Injectable
- 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)
- Lot #: 20180123@4
- BUD 4/14/2018.
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 49 recalled by Partell Specialty 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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