Apothecary Shoppe Recalls Estradiol and Progesterone Injectable Due to Sterility Concerns
The Apothecary Shoppe is recalling Estradiol and Progesterone injectable vials due to concerns about sterility assurance 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. Per the rubric, FDA Class II recalls involving significant injury/property-damage reports or hospitalization are Severe; while no specific injuries are reported, the lack of sterility assurance in an injectable drug poses a significant risk of serious harm, aligning with the Severe classification for high-risk drug defects.
Plain-English summary
The Apothecary Shoppe is recalling Estradiol 1.25 mg, Progesterone 25 mg/mL injectable, 20 mL sterile vials. The recall was initiated due to a lack of assurance of sterility, specifically regarding concerns with the pharmacy's independent testing laboratory.
The affected product is identified by Lot 05022013@20 with an expiration date of 10/29/13. The total quantity involved is 3,540 mL, and the product was distributed in Oklahoma.
Consumers and healthcare providers should stop using the recalled product and contact the Apothecary Shoppe or their healthcare provider for further instructions.
The recalled product
- Product
- Estradiol 1.25 mg, Progesterone 25 mg/mL injectable, 20 mL sterile vials, The Apothecary Shoppe, 6136 E. 51st St. Tulsa, OK 74135.
- Manufacturer
- Apothecary Shoppe
- Category
- Drug — Injectable
- Hazard
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 05022013@20
- Exp 10/29/13
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 2 recalled by Apothecary Shoppe under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
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