Specialty Medicine Compounding Pharmacy Recalls Potassium Phosphate Injectable Due to Sterility Concerns
Specialty Medicine Compounding Pharmacy is recalling Potassium Phosphate injectable 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 recall is classified as FDA Class II, which corresponds to a Severe severity score under the rubric for significant injury or property damage reports or high-risk scenarios.
Plain-English summary
Specialty Medicine Compounding Pharmacy is recalling all unexpired lots of Potassium Phosphate PF 4.4 MEQ (3MM)/mL Injectable. The recall covers 600 mL units manufactured and distributed between July 1, 2013, and October 19, 2013, including Lot # 10032013@2 and Lot # 10032013@1.
The recall 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 Potassium Phosphate 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 the recalling firm for further instructions.
The recalled product
- Product
- POTASSIUM PHOSPHATE* PF 4.4 MEQ (3MM)/mL 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 (4)
- All unexpired lots
- manufactured and distributed between 07/01/2013 and 10/19/2013
- including Lot #: 10032013@2
- 10032013@1
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
Same manufacturer · Specialty Medicine Compounding Pharmacy
See all →- Severe
- SevereSpecialty Medicine Compounding Pharmacy Recalls Combo Eye Gel Due to Sterility Concerns
FDA (Drugs) · 2014-01-22
- SevereHyaluronidase Recalled Due to Lack of Assurance of Sterility
FDA (Drugs) · 2014-01-22
- SeverePhenol Injectable Recalled Due to Lack of Sterility Assurance
FDA (Drugs) · 2014-01-22
- SevereCyanocobalamin Injectable Recalled Due to Sterility Assurance Concerns
FDA (Drugs) · 2014-01-22
Same hazard · lack of sterility
See all →- HighRohto Cooling Eye Drops Max Strength Recalled Due to Sterility Concerns
FDA (Drugs) · 2026-07-29
- HighRohto Cooling Eye Drops Recalled Due to Lack of Assurance of Sterility
FDA (Drugs) · 2026-07-29
- SevereCleviprex Injectable Emulsion Recall Due to Sterility Assurance Concerns
FDA (Drugs) · 2026-07-22
- SeverePemetrexed for Injection recalled due to lack of sterility assurance
FDA (Drugs) · 2026-07-15
- SevereAzacitidine for Injection Recalled for Lack of Sterility Assurance
FDA (Drugs) · 2026-07-15