The Recall Desk
SevereFDA (Drugs)·D-1063-2013·Announced 2013-10-02

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.

What this means for you

Illness, injury, or structural failure has been reported. 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
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.