The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-459-2014·Announced 2014-01-22

Specialty Medicine Compounding Pharmacy Recalls Sterile Compounded Products Due to Sterility Concerns

Specialty Medicine Compounding Pharmacy is recalling unexpired sterile compounded human and veterinary products because sterility cannot be assured after a related product was found 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 FDA classified this as a Class II recall. Per the rubric, FDA Class II recalls with potential for adverse health consequences (such as sterility assurance failures in injectable products) are categorized as Severe.

Plain-English summary

Specialty Medicine Compounding Pharmacy is recalling all unexpired sterile compounded human and veterinary products. The recall is being conducted because these 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 products cannot be assured.

The affected products include DT- Tranexamic Acid* 2 gm/100 mL Drug Study -IV 100 mL injectable and DT-Tranexamic Acid* 2 gm/100 mL-Drug Study-Topical 100 mL Rx only. The recall covers all unexpired lots manufactured and distributed between July 1, 2013, and October 19, 2013. Specific lot numbers include Injectable 09252013@10, 09302013@1, and 10152013@5, as well as Topical 09252013@11, 09302013@3, and 10152013@7.

The products were distributed to hospitals, clinics, physicians, and patients in the Michigan area only. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote. Consumers and healthcare providers should stop using these products and contact the recalling firm or their healthcare provider for further instructions.

The recalled product

Product
DT- Tranexamic Acid* 2 gm/100 mL Drug Study -IV 100 mL injectable, DT-, DT-Tranexamic Acid* 2 gm/100 mL-Drug Study-Topical 100 mL Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178
Manufacturer
Specialty Medicine Compounding Pharmacy
Category
Drug — Compounded Sterile Products
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 (8)

  • All unexpired lots
  • manufactured and distributed between 07/01/2013 and 10/19/2013
  • including Lot #s: a) Injectable 09252013@10
  • 09302013@1
  • 10152013@5
  • b) Topical 09252013@11
  • 09302013@3
  • 10152013@7

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 →

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