Why it was recalled
Lack of Assurance of Sterility: Walgreens Specialty Pharmacy is recalling one lot of Progesterone in Ethyl Oleate sterile injection due to concerns of sterility assurance with the specialty pharmacy's independent testing laboratory.
Product description
Walgreens Progesterone in Ethyl Oleate 50 mg per mL Injection, 10 mL vial, Inject 1 mL Intramuscularly as directed by physician, Walgreens Specialty Pharmacy, Fresco, TX.
Lot numbers, UPCs & expiration codes
Lot #: P50EO07121390A, Exp 1/12/14
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-1063-2013
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Aug 23, 2013
- FDA report date
- Oct 2, 2013
- Quantity
- 298 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Walgreens Co
Original FDA data
Every field from FDA enforcement report D-1063-2013, exactly as published.
Show all FDA fields
- City
- Deerfield
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 66330
- Address
- 200 Wilmot Rd
- Code information
- Lot #: P50EO07121390A, Exp 1/12/14
- Postal code
- 60015-4620
- Report date
- Oct 2, 2013
- Product type
- Drugs
- Recall number
- D-1063-2013
- Classification
- Class II
- Recalling firm
- Walgreens Co
- Product quantity
- 298 vials
- Termination date
- Jun 19, 2014
- Reason for recall
- Lack of Assurance of Sterility: Walgreens Specialty Pharmacy is recalling one lot of Progesterone in Ethyl Oleate sterile injection due to concerns of sterility assurance with the specialty pharmacy's independent testing laboratory.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Walgreens Progesterone in Ethyl Oleate 50 mg per mL Injection, 10 mL vial, Inject 1 mL Intramuscularly as directed by physician, Walgreens Specialty Pharmacy, Fresco, TX.
- Distribution pattern
- Nationwide
- Recall initiation date
- Aug 23, 2013
- Initial firm notification
- Telephone
- Center classification date
- Sep 26, 2013