Specialty Medicine Compounding Pharmacy Recalls 0.9% Sodium Chloride Due to Sterility Concerns
Specialty Medicine Compounding Pharmacy is recalling 0.9% Sodium Chloride injectable and topical 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 FDA classified this as a Class II recall involving a lack of assurance of sterility in compounded products, which aligns with the rubric criteria for Severe severity (FDA Class II with potential for serious health consequences).
Plain-English summary
Specialty Medicine Compounding Pharmacy is recalling 0.9% Sodium Chloride products, including 100 mL injectable and topical drug study formulations. The recall covers all unexpired lots manufactured and distributed between July 1, 2013, and October 19, 2013. Specific lot numbers include 09252013@8, 09302013@2, and 10152013@6 for the injectable form, and 09252013@9, 09302013@5, and 10152013@8 for the topical form.
The recall is being conducted 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 sodium chloride products cannot be assured. The FDA has classified this recall as Class II.
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
- 0.9% Sodium chloride a) DT-0.9% Sodium chloride* 100 mL Drug Study - IV 100 mL Injectable, b) DT-0.9% Sodium Chloride* 100 mL Drug Study - Topical, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178
- Manufacturer
- Specialty Medicine Compounding Pharmacy
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 (8)
- All unexpired lots
- manufactured and distributed between 07/01/2013 and 10/19/2013
- including Lot #s: a) Injectable 09252013@8
- 09302013@2
- 10152013@6
- b) Topical 09252013@9
- 09302013@5
- 10152013@8
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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