Specialty Medicine Compounding Pharmacy Recalls Naltrexone MDV Injectable
Specialty Medicine Compounding Pharmacy is recalling Naltrexone MDV 1mg/mL injectable because sterility cannot be assured due to shared compounding practices with a non-sterile product.
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 and involves a lack of assurance of sterility in an injectable product, which poses a risk of serious infection or adverse health consequences, meeting the criteria for a Severe rating.
Plain-English summary
Specialty Medicine Compounding Pharmacy is recalling Naltrexone MDV 1mg/mL injectable, a prescription-only sterile compounded product. The recall includes all unexpired lots manufactured and distributed between July 1, 2013, and October 19, 2013, including Lot # 09262013@3. The product was distributed to hospitals, clinics, physicians, and patients in the Michigan area only.
The recall is being conducted because the recalled products were compounded in the same environment and under the same practices as another product that was found to be non-sterile. As a result, the sterility of the Naltrexone MDV injectable cannot be assured. This lack of assurance of sterility applies to all unexpired sterile compounded human and veterinary products from the facility during this period.
Consumers and healthcare providers should stop using the recalled product and contact their healthcare provider or the recalling firm for further instructions. The FDA classifies this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- NALTREXONE* MDV 1MG/ML INJECTABLE, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178
- Manufacturer
- Specialty Medicine Compounding Pharmacy
- Category
- Drug — Injectable
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 (3)
- All unexpired lots
- manufactured and distributed between 07/01/2013 and 10/19/2013
- including Lot #: 09262013@3
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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