Specialty Medicine Compounding Pharmacy Recalls Epinephrine Due to Sterility Concerns
Specialty Medicine Compounding Pharmacy is recalling Epinephrine products because sterility cannot be assured after a related product was found non-sterile.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classification is FDA Class II, and the recall involves a lack of assurance of sterility for compounded products, which aligns with the rubric criteria for Severe severity involving significant risk or agency classification.
Plain-English summary
Specialty Medicine Compounding Pharmacy is recalling Epinephrine PF SF (0.3 mL), (1 mL), and (0.5 mL in 3 mL syringe) 1:1000 Ophthalmic Solution. The recall includes all unexpired lots manufactured and distributed between July 1, 2013, and October 19, 2013.
The recall is being conducted because the sterile compounded human and veterinary products were compounded in the same environment and under the same practices as another product found to be non-sterile. Consequently, the sterility of the recalled Epinephrine products cannot be assured.
The affected products were distributed to hospitals, clinics, physicians, and patients in the Michigan area only. Consumers and healthcare providers should stop using the recalled products and contact their healthcare provider or the pharmacy for further instructions.
The recalled product
- Product
- EPINEPHRINE PF SF* (0.3 mL); (1 mL), (0.5 mL IN 3 mL SYRINGE) 1:1000 OPHTH SOL, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178
- Manufacturer
- Specialty Medicine Compounding Pharmacy
- 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 (9)
- All unexpired lots
- manufactured and distributed between 07/01/2013 and 10/19/2013
- including Lot #s: 10082013@7
- 10152013@2
- t10102013@1
- t10092013@7
- t10092013@6
- t10142013@60
- t10142013@61
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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