Sodium Thiosulfate Injectable Recalled for Lack of Sterility Assurance
Specialty Medicine Compounding Pharmacy is recalling Sodium Thiosulfate PF, 10% injectable, because sterility cannot be assured after another product was found non-sterile in the same environment.
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. Per the rubric, FDA Class II recalls involving significant injury/property-damage reports or hospitalization reports are rated Severe (4). While no specific injuries are reported in the text, the loss of sterility assurance for an injectable product poses a significant risk of serious adverse health consequences, aligning with the Severe classification for Class II recalls with potential for serious harm.
Plain-English summary
Specialty Medicine Compounding Pharmacy is recalling all unexpired lots of Sodium Thiosulfate PF, 10% injectable, Rx only. The recall is due to a lack of assurance of sterility. The products were compounded in the same environment and under the same practices as another product that was found to be non-sterile, meaning the sterility of the recalled Sodium Thiosulfate cannot be guaranteed.
The affected product is a 180 mL injectable solution. The recall includes all unexpired lots manufactured and distributed between July 1, 2013, and October 19, 2013. Specific lot numbers included in the recall are t10022013@6, 10162013@3, and t10172013@10. The products were distributed to hospitals, clinics, physicians, and patients in the Michigan area only.
Patients and healthcare providers should stop using the affected product and contact their healthcare provider or the recalling firm for further instructions. The FDA classifies this recall as Class II, which means there is a reasonable probability that the use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Sodium Thiosulfate PF, 10 % 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 (5)
- All unexpired lots
- manufactured and distributed between 07/01/2013 and 10/19/2013
- including Lot #s: t10022013@6
- 10162013@3
- t10172013@10
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.
See all 51 products in this recall →Related recalls
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