Why it was recalled
Crystallization: Formation of crystals observed in product.
Product description
HYDROXYPROGESTERONE CAPROATE 250 MG/ML (IN SESAME OIL), Rx Only 4 mL INJECTABLE IM USE. Manufactured by Avella Specialty Pharmacy, Phoenix, AZ 85085.
Lot numbers, UPCs & expiration codes
Lot# 12-20140207@109; Exp. 12/14 Lot# 12-20142107@82; Exp. 01/15
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-0016-2014
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Oct 1, 2014
- FDA report date
- Oct 22, 2014
- Quantity
- 197 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Avella of Deer Valley, Inc.
Original FDA data
Every field from FDA enforcement report D-0016-2014, exactly as published.
Show all FDA fields
- City
- Phoenix
- State
- AZ
- Status
- Terminated
- Country
- United States
- Event ID
- 69405
- Address
- 23620 N 20th Dr Ste 12
- Code information
- Lot# 12-20140207@109; Exp. 12/14 Lot# 12-20142107@82; Exp. 01/15
- Postal code
- 85085-0621
- Report date
- Oct 22, 2014
- Product type
- Drugs
- Recall number
- D-0016-2014
- Classification
- Class II
- Recalling firm
- Avella of Deer Valley, Inc.
- Product quantity
- 197 vials
- Termination date
- Feb 20, 2015
- Reason for recall
- Crystallization: Formation of crystals observed in product.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- HYDROXYPROGESTERONE CAPROATE 250 MG/ML (IN SESAME OIL), Rx Only 4 mL INJECTABLE IM USE. Manufactured by Avella Specialty Pharmacy, Phoenix, AZ 85085.
- Distribution pattern
- Nationwide
- Recall initiation date
- Oct 1, 2014
- Initial firm notification
- Telephone
- Center classification date
- Oct 10, 2014