The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0182-2016·Announced 2015-11-18

The Compounder Recalls Biest 66/34 Due to Penicillin Cross-Contamination

The Compounder is recalling Biest 66/34 hormone suspension because an active ingredient was contaminated with penicillin. Patients should stop using the product and consult a healthcare provider.

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. Per the rubric, FDA Class II recalls with potential for adverse health consequences (such as penicillin contamination) are assigned a score of 4 (Severe).

Plain-English summary

The Compounder is recalling specific lots of Biest 66/34: Testosterone : Progesterone in Olive Oil, a prescription-only hormone suspension. The recall was initiated because the product was manufactured using an active ingredient that was previously recalled by a supplier due to penicillin cross-contamination.

The affected product is packaged in 15 mL glass dropper bottles. The recall includes Lot # 12192014:35@1 (Expiration 6/17/2015) and Lot # 02202015:68@46 (Expiration 8/19/2015). The distribution pattern for these products is listed as nationwide.

Patients who have this product should stop using it and consult their healthcare provider. The recall is classified as FDA Class II, indicating a situation where use of, or exposure to, the product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product
BIEST 66/34: TESTOSTERONE : PROGESTERONE IN OLIVE OIL(Estradiol USP Micronized (ED)/Estriol USP Micronized (E3): Testosterone : Progesterone in Olive Oil) 3mg : 4 mg : 100 mg/mL suspension, Rx only, packaged in a 15 mL glass dropper bottle. The Compounder, 340 Marshall Avenue…
Manufacturer
the Compounder
Category
Drug — Compounded Prescription
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 (4)

  • Lot # 12192014:35@1
  • Exp 6/17/2015
  • Lot # 02202015:68@46
  • Exp 8/19/15

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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Same hazard · penicillin contamination

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