D-1063-2013 Class II Terminated
FDA drug recall D-1063-2013 was initiated by Walgreens Co on August 23, 2013 and is designated Class II. 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… The recall status is terminated (terminated June 19, 2014). Affected quantity: 298 vials.
Recall Details
- Product Type
- Drugs
- Report Date
- October 2, 2013
- Initiation Date
- August 23, 2013
- Termination Date
- June 19, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 298 vials
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.
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.
Distribution Pattern
Nationwide
Code Information
Lot #: P50EO07121390A, Exp 1/12/14