Why it was recalled
Crystallization; visible crystals from the active ingredient formed due to extreme cold temperatures during shipping
Product description
Hydroxyprogesterone Caproate 250mg/ml in Sesame Oil, 1 ml injectable solution, in 3 ml single dose syringes; a multi-ingredient compounded medication in bulk, containing Benzoyl Benzoate USP 0.46 ml/1ml, and Benzyl Alcohol 0.02 ml/1ml; syringe is labeled in part ***FOR INJECTION USE ONLY***RX South LLC DBA RX3 12230 Iron Bridge Rd Chester, VA 23831***
Lot numbers, UPCs & expiration codes
Lot number: 12052013:03 Expiration date: 06/03/2014
Where it was sold
Product was distributed in Virginia and Maryland.
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-1164-2014
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jan 28, 2014
- FDA report date
- Mar 26, 2014
- Quantity
- 250 syringes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- RX South LLC DBA RX3 Pharmacy
Original FDA data
Every field from FDA enforcement report D-1164-2014, exactly as published.
Show all FDA fields
- City
- Chester
- State
- VA
- Status
- Terminated
- Country
- United States
- Event ID
- 67432
- Address
- 12230 Iron Bridge Rd
- Address (line 2)
- Ste. C
- Code information
- Lot number: 12052013:03 Expiration date: 06/03/2014
- Postal code
- 23831-1534
- Report date
- Mar 26, 2014
- Product type
- Drugs
- Recall number
- D-1164-2014
- Classification
- Class II
- Recalling firm
- RX South LLC DBA RX3 Pharmacy
- Product quantity
- 250 syringes
- Termination date
- Apr 10, 2014
- Reason for recall
- Crystallization; visible crystals from the active ingredient formed due to extreme cold temperatures during shipping
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Hydroxyprogesterone Caproate 250mg/ml in Sesame Oil, 1 ml injectable solution, in 3 ml single dose syringes; a multi-ingredient compounded medication in bulk, containing Benzoyl Benzoate USP 0.46 ml/1ml, and Benzyl Alcohol 0.02 ml/1ml; syringe is labeled in part ***FOR INJECTION USE ONLY***RX South LLC DBA RX3 12230 Iron Bridge Rd Chester, VA 23831***
- Distribution pattern
- Product was distributed in Virginia and Maryland.
- Recall initiation date
- Jan 28, 2014
- Initial firm notification
- Letter
- Center classification date
- Mar 17, 2014