Walgreens Recalls Progesterone Injection Lot Due to Sterility Concerns
Walgreens Specialty Pharmacy is recalling one lot of Progesterone in Ethyl Oleate injection due to sterility assurance concerns with its testing laboratory.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II. According to the rubric, FDA Class II recalls with potential for serious injury or hospitalization (implied by sterility failure in an injectable drug) fall under the Severe category (Score 4).
Plain-English summary
Walgreens Specialty Pharmacy is recalling one lot of Progesterone in Ethyl Oleate 50 mg per mL Injection, 10 mL vials. The recall involves 298 vials distributed nationwide. The specific lot number is P50EO07121390A, with an expiration date of 1/12/14.
The recall was initiated due to a lack of assurance of sterility. The source text indicates that the concerns relate to the specialty pharmacy's independent testing laboratory. The FDA has classified this recall as Class II.
Consumers who have this specific product should stop using it and contact their healthcare provider or Walgreens for further instructions. Do not use the product if the lot number matches P50EO07121390A.
The recalled product
- Product
- 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.
- Manufacturer
- Walgreens Co
- Category
- Drug — Injectable Sterile
- Affected units
- 298
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot #: P50EO07121390A
- Exp 1/12/14
Distribution
Distributed nationwide across the United States.
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