The Recall Desk
SevereFDA (Drugs)·D-0124-2022·Announced 2021-11-17

Medroxyprogesterone Acetate Suspension Recalled for Sterility Concerns

Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling Medroxyprogesterone Acetate 150 mg/mL suspension because the manufacturer cannot assure the product's sterility.

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: This is an FDA Class II recall involving a sterile injectable product where sterility assurance cannot be provided. Loss of sterility in injectable medications poses a serious risk of infection and could require hospitalization, meeting the Class II with risk-of-serious-injury criterion.

Plain-English summary

Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling 696 vials of Medroxyprogesterone Acetate 150 mg/mL suspension (Rx only) distributed across the United States, including Washington, D.C. and Puerto Rico.

The recall was initiated because the manufacturer lacks assurance of the product's sterility. The affected lots are: 07222021:40 (BUD 10/20/2021), 03302021:60 (BUD 10/26/2021), 04122021:29 (BUD 11/08/2021), 08172021:38 (BUD 11/15/2021), and 07072021:60 (BUD 10/05/2021).

Healthcare providers and patients who have received or are holding this product should contact their pharmacy or healthcare provider. Patients should not use the recalled product without consulting their healthcare provider.

The recalled product

Product
MEDROXYPROGESTERONE ACET 150MG/ML SUSP (PF) 150MG/ML SUSPENSION, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247
Manufacturer
Vita Pharmacy, LLC dba Talon Compounding Pharmacy
Category
Drug — Injectable / Compounded Pharmaceutical
Hazard
  • lack-of-sterility
  • contamination-risk
  • infection-risk

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 (5)

  • Lot: 07222021:40 BUD: 10/20/2021
  • 03302021:60 BUD: 10/26/2021
  • 04122021:29 BUD: 11/08/2021
  • 08172021:38 BUD: 11/15/2021
  • 07072021:60 BUD: 10/05/2021

Distribution

Distribution scope not specified by the agency.

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