Guardian Pharmacy Recalls Medroxyprogesterone Vials Due to Sterility Concerns
Guardian Pharmacy Services is recalling 60 vials of compounded Medroxyprogesterone 150 mg/mL in Texas due to a lack of sterility assurance.
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 rated Severe. While specific injury reports are not detailed in the text, the agency classification and the nature of the defect (sterility) align with the Severe criteria for Class II recalls.
Plain-English summary
Guardian Pharmacy Services is recalling 60 5-mL vials of compounded Medroxyprogesterone 150 mg/mL. The product is prescription-only and was distributed in Texas. The recall was initiated due to a lack of sterility assurance.
The affected lots are 58611:42 (Use By: 06/07/2018), 59099:42 (Use By: 07/24/2018), and 58786:42 (Use By: 06/24/2018). The product was manufactured by Guardian Pharmacy Services, located at 7920 Elmbrook Dr. Ste. 108C, Dallas, TX 75247.
Consumers and healthcare providers should stop using the recalled product and contact their pharmacist or physician for further instructions.
The recalled product
- Product
- Medroxyprogesterone 150 mg/mL 5ml. Rx Only. Packaged in 5 mL vials. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247
- Manufacturer
- Guardian Pharmacy Services
- Category
- Drug — Compounded 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 (3)
- Lots: 58611:42 Use By: 06/07/2018
- 59099:42 Use By: 07/24/2018
- 58786:42 Use By: 06/24/2018
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 23 recalled by Guardian Pharmacy Services 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.
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