The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0209-2016·Announced 2015-11-18

The Compounder Recalls Biest TD 83/17 Cream Due to Penicillin Contamination

The Compounder is recalling Biest TD 83/17 transdermal cream because the active ingredient was contaminated with penicillin. The recall is nationwide.

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 agency classification is FDA Class II, and the rubric specifies that FDA Class II recalls with potential for significant injury (such as penicillin contamination) are rated as Severe.

Plain-English summary

The Compounder is recalling Biest TD 83/17, a prescription transdermal cream containing estradiol and estriol. The product is dispensed in 10 mL prefilled amber syringes. The recall is being conducted nationwide.

The recall was initiated because the active ingredient used to manufacture the product was recalled by a supplier due to penicillin cross-contamination. The specific lot number is 01052015:05@12, with an expiration date of 7/4/2015. The quantity involved is 6 (10mL) syringes.

Consumers who have this product should stop using it and contact their healthcare provider or pharmacist for further instructions. The FDA has classified this recall as Class II.

The recalled product

Product
BIEST TD 83/17 (Estradiol (E2) Trit (Yellow)/Estriol USP Micronized (E3) W/V (weight/volume) 1.2 MG/ML Transdermal cream, dispensed in 10 mL prefilled, amber syringes, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.
Manufacturer
the Compounder
Category
Drug — Transdermal Cream
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 (2)

  • Lot # 01052015:05@12
  • Exp 7/4/2015

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 47 recalled by the Compounder 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 47 products in this recall →

Related recalls

Same manufacturer · the Compounder

See all →

Same hazard · penicillin contamination

See all →

Similar recalls