The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0189-2016·Announced 2015-11-18

The Compounder Recalls Biest TD 67/33 Transdermal Cream Due to Penicillin Contamination

The Compounder is recalling Biest TD 67/33 transdermal cream because the active ingredient was contaminated with penicillin. The recall covers 10 syringes per lot distributed 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 recall is classified as FDA Class II, which corresponds to a Severe severity score under the rubric. The hazard involves penicillin cross-contamination, a significant risk for patients with penicillin allergies.

Plain-English summary

The Compounder is recalling Biest TD 67/33 (Estradiol/Estriol) transdermal cream, a prescription-only medication dispensed in 3 mL prefilled amber syringes. The recall is being conducted because the active ingredient used to manufacture the product was recalled by a supplier due to penicillin cross-contamination.

The affected product is identified by Lot # 03022015:71@18 with an expiration date of 8/29/2015. The recall quantity is 10 (3mL) syringes. The product was distributed nationwide.

Consumers and healthcare providers should stop using the recalled product and contact their healthcare provider or The Compounder for further instructions. The recall was initiated by The Compounder, located at 340 Marshall Avenue Unit 100, Aurora, IL 60506.

The recalled product

Product
BIEST TD 67/33 (Estradiol (E2) TRIT (YELLOW)/Estriol USP Micronized (E3)) W/V (weight /volume) 1.5 MG/ML Transdermal cream, dispensed in 3 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 # 03022015:71@18
  • Exp 8/29/2015

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 →

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