Specialty Medicine Compounding Pharmacy Recalls WB-Tranexamic Acid Due to Sterility Concerns
Specialty Medicine Compounding Pharmacy is recalling WB-Tranexamic acid products because sterility cannot be assured after a related product was found to be 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, and the rubric specifies that FDA Class II recalls with potential for serious injury or hospitalization (implied by sterility failure in injectable drugs) fall under the Severe category.
Plain-English summary
Specialty Medicine Compounding Pharmacy is recalling WB-Tranexamic acid, 2 g/Placebo 100 mL, DRUG STUDY products. The recalled items are packaged as 100 mL injectable and topical formulations and are prescription-only. The recall includes 1,900 injectable units and 1,900 mL of topical product.
The recall is being conducted due to a lack of assurance of sterility. 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 WB-Tranexamic acid products cannot be assured. All unexpired lots manufactured and distributed between July 1, 2013, and October 19, 2013, are affected.
The 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 recalling firm for further instructions.
The recalled product
- Product
- WB-Tranexamic acid, 2 g/Placebo 100 mL, DRUG STUDY, packaged as a) 100 mL INJECTABLE, b) 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 (20)
- All unexpired lots
- manufactured and distributed between 07/01/2013 and 10/19/2013
- including Lot #s: a) Injectable lots: 09272013@14
- 09272013@4
- 09272013@8
- 09272013@18
- 10142013@3
- 10142013@9
- 10142013@13
- 10142013@15
- 10142013@19
- 09272013@3
- 09272013@7
- 09272013@11
- 09272013@13
- 09272013@17
- 10142013@6
- 10142013@8
- 10142013@12
- 10142013@18
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 · sterility failure
See all →- SevereROHTO DIGI-EYE Eye Drops Recalled Over Sterility Assurance Gap
FDA (Drugs) · 2026-07-29
- HighROHTO DRY-AID Eye Drops Recalled Due to Sterility Concerns
FDA (Drugs) · 2026-07-29
- SevereTransvenous Pacing Electrode Tray with Bipolar Balloon Pacing Electrode Recalled
FDA (Devices) · 2026-07-22
- SevereArterial Line Kit with Lidocaine HCL Injection Fails Sterility Testing
FDA (Devices) · 2026-07-22
- SevereOne-Piece Introducer Tray kits recalled for sterility failure
FDA (Devices) · 2026-07-22