Why it was recalled
Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.
Product description
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 Unit 100, Aurora, IL 60506.
Lot numbers, UPCs & expiration codes
Lot # 12192014:35@1, Exp 6/17/2015; Lot # 02202015:68@46, Exp 8/19/15
Where it was sold
Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0182-2016
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Mar 10, 2015
- FDA report date
- Nov 18, 2015
- Quantity
- 3 (15mL) bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- the Compounder
Original FDA data
Every field from FDA enforcement report D-0182-2016, exactly as published.
Show all FDA fields
- City
- Aurora
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 71535
- Address
- 340 Marshall Ave Unit 100
- Code information
- Lot # 12192014:35@1, Exp 6/17/2015; Lot # 02202015:68@46, Exp 8/19/15
- Postal code
- 60506-5649
- Report date
- Nov 18, 2015
- Product type
- Drugs
- Recall number
- D-0182-2016
- Classification
- Class II
- Recalling firm
- the Compounder
- Product quantity
- 3 (15mL) bottles
- Termination date
- May 19, 2016
- Reason for recall
- Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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 Unit 100, Aurora, IL 60506.
- Distribution pattern
- Nationwide
- Recall initiation date
- Mar 10, 2015
- Initial firm notification
- Telephone
- Center classification date
- Nov 10, 2015