Agency classClass IIOur severity:Severe FDA (Drugs)·D-456-2014·Announced 2014-01-22

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.

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 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
Category: Drug — Compounded Sterile Preparations
Hazard: sterility-failure
infection-risk

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 →

Same manufacturer · Specialty Medicine Compounding Pharmacy

See all →

Severe
Specialty Medicine Compounding Pharmacy Recalls Sterile Compounded Products Due to Sterility Concerns
FDA (Drugs) · 2014-01-22
Severe
Specialty Medicine Compounding Pharmacy Recalls Combo Eye Gel Due to Sterility Concerns
FDA (Drugs) · 2014-01-22
Severe
Hyaluronidase Recalled Due to Lack of Assurance of Sterility
FDA (Drugs) · 2014-01-22
Severe
Phenol Injectable Recalled Due to Lack of Sterility Assurance
FDA (Drugs) · 2014-01-22
Severe
Cyanocobalamin Injectable Recalled Due to Sterility Assurance Concerns
FDA (Drugs) · 2014-01-22

Same hazard · sterility failure