Naloxone Injectable Recalled Due to Lack of Assurance of Sterility
Specialty Medicine Compounding Pharmacy is recalling Naloxone HCL 0.4mg/mL injectable because sterility cannot be assured after a related product was found to be non-sterile.
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 medication, which poses a significant risk of serious injury or infection.
Plain-English summary
Specialty Medicine Compounding Pharmacy is recalling all unexpired lots of Naloxone HCL 0.4mg/mL injectable. The recall includes all sizes and was initiated because the products were compounded 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 Naloxone products cannot be assured.
The affected products were manufactured and distributed between July 1, 2013, and October 19, 2013. The recall specifically includes Lot # 08292013@10 and all other unexpired lots from this period. The products were distributed to hospitals, clinics, physicians, and patients in the Michigan area only.
Consumers and healthcare providers should stop using the recalled Naloxone HCL 0.4mg/mL injectable and contact their healthcare provider or the pharmacy for further instructions on disposal or replacement.
The recalled product
- Product
- NALOXONE HCL* 0.4MG/ML INJECTABLE, all sizes, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178
- Manufacturer
- Specialty Medicine Compounding Pharmacy
- Category
- Drug — Injectable Medication
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 #: 08292013@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.
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