Why it was recalled
Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance
Product description
DUAL-TESTOSTERONE 20, 50, 100, 150, 200 MG/ML OIL INJ SOLN, all presentations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI
Lot numbers, UPCs & expiration codes
05302013@6, 02112013@5, 04192013@21, 05032013@14, 01252013@11, 03272013@17, 01252013@8, 03272013@22, 01312013@9, 06062013@24, 01032013@1, 01152013@14, 01292013@4, 01312013@10, 02142013@9, 03062013@10, 03112013@6, 03112013@4, 04042013@16, 04122013@18, 04302013@24, 05102013@18, 05282013@29, 06042013@18, 06282013@10, 07112013@21, 07232013@1, 07282013@1, 07282013@2, 01312013@8, 05222013@26.
Where it was sold
USA 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-952-2013
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jul 26, 2013
- FDA report date
- Sep 18, 2013
- Quantity
- N/A
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Beacon Hill Medical Pharmacy, P.C.
Original FDA data
Every field from FDA enforcement report D-952-2013, exactly as published.
Show all FDA fields
- City
- Southfield
- State
- MI
- Status
- Terminated
- Country
- United States
- Event ID
- 65876
- Address
- 18161 W 13 Mile Rd
- Address (line 2)
- Suite A1
- Code information
- 05302013@6, 02112013@5, 04192013@21, 05032013@14, 01252013@11, 03272013@17, 01252013@8, 03272013@22, 01312013@9, 06062013@24, 01032013@1, 01152013@14, 01292013@4, 01312013@10, 02142013@9, 03062013@10, 03112013@6, 03112013@4, 04042013@16, 04122013@18, 04302013@24, 05102013@18, 05282013@29, 06042013@18, 06282013@10, 07112013@21, 07232013@1, 07282013@1, 07282013@2, 01312013@8, 05222013@26.
- Postal code
- 48076-1113
- Report date
- Sep 18, 2013
- Product type
- Drugs
- Recall number
- D-952-2013
- Classification
- Class II
- Recalling firm
- Beacon Hill Medical Pharmacy, P.C.
- Termination date
- Jul 18, 2014
- Reason for recall
- Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- DUAL-TESTOSTERONE 20, 50, 100, 150, 200 MG/ML OIL INJ SOLN, all presentations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI
- Distribution pattern
- USA nationwide
- Recall initiation date
- Jul 26, 2013
- Initial firm notification
- Telephone
- Center classification date
- Sep 10, 2013