The Compounder Recalls Transdermal Cream Due to Penicillin Cross-Contamination
The Compounder is recalling specific lots of a compounded transdermal cream because an active ingredient was contaminated with penicillin.
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 hazard involves penicillin cross-contamination, which poses a risk of significant allergic reaction or injury.
Plain-English summary
The Compounder is recalling a specific lot of a compounded transdermal cream containing estradiol, progesterone, and testosterone. The product is dispensed in 10 mL prefilled amber syringes and is available by prescription only.
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 lot is identified as Lot # 01132015:27@20, with an expiration date of 7/12/2015. The recall covers 6 (10mL) syringes distributed nationwide.
Consumers who have this specific product should stop using it and contact their healthcare provider or pharmacist for guidance on disposal or replacement.
The recalled product
- Product
- ESTRIOL (E3) : ESTRADIOL (E2) (Estradiol (E2) Trit (Yellow)) : PROGEST (Progesterone USP) : TESTO (Testosterone USP) W/V (weight/volume) 2 :0.1 : 35 : 0.5 MG/ML Transdermal cream, dispensed in 10 mL prefilled, amber syringes, Rx only, The Compounder, 340 Marshall Avenue Unit…
- Manufacturer
- the Compounder
- Category
- Drug — Compounded Prescription
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 # 01132015:27@20
- Exp 7/12/2015
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
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