Specialty Medicine Compounding Pharmacy Recalls Hydroxocobalamin/Thiamine Injectable
Specialty Medicine Compounding Pharmacy is recalling Hydroxocobalamin/Thiamine Injectable due to lack of assurance of sterility. The product was distributed to healthcare providers in Michigan.
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 sterility assurance issues for injectable products.
Plain-English summary
Specialty Medicine Compounding Pharmacy is recalling all unexpired lots of Hydroxocobalamin/Thiamine 1 mg/100 mg/mL Injectable. The recall is being conducted because the sterile compounded products were manufactured in the same environment and under the same practices as another product that was found to be non-sterile. Consequently, the sterility of the recalled product cannot be assured.
The affected product is a prescription-only injectable with a quantity of 53 mL. The recall includes all unexpired lots manufactured and distributed between July 1, 2013, and October 19, 2013, specifically including Lot #s 09192013@10 and 10152013@19. The product was distributed to hospitals, clinics, physicians, and patients in the Michigan area only.
Healthcare providers and patients should stop using the recalled product and contact the recalling firm or their healthcare provider for further instructions. The FDA classifies this recall as Class II, indicating a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- HYDROXOCOBALAMIN/THIAMINE* 1 mg/100 mg/mL INJECTABLE, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178
- Manufacturer
- Specialty Medicine Compounding Pharmacy
- 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 (4)
- All unexpired lots
- manufactured and distributed between 07/01/2013 and 10/19/2013
- including Lot #s: 09192013@10
- 10152013@19
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 51 recalled by Specialty Medicine Compounding 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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