The Recall Desk
SevereFDA (Drugs)·D-0263-2016·Announced 2015-11-25

US Compounding Recalls Medroxyprogesterone/Lidocaine Vials Due to Sterility Concerns

US Compounding Inc is recalling 439 vials of Medroxyprogesterone/Lidocaine due to deficient practices that may impact sterility assurance.

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. Per the rubric, FDA Class II recalls with potential for adverse health consequences (such as sterility failure in injectable drugs) are categorized as Severe.

Plain-English summary

US Compounding Inc is recalling 439 vials of MedroxyPROGESTERone/Lidocaine (150 mg/mL/1%) 10 mL Multi-Dose Vials. The product is compounded by US Compounding Pharmacy in Conway, Arkansas, and is distributed nationwide. The recall includes specific lot numbers with expiration dates in November 2015.

The recall was initiated due to a lack of assurance of sterility. The firm identified deficient practices that may have an impact on sterility assurance for all sterile preparations within their expiry. This is a Class II recall, indicating a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

Patients who have received this medication should consult their healthcare provider for guidance. The source text does not report any specific illnesses or injuries associated with this recall.

The recalled product

Product
MedroxyPROGESTERone/Lidocaine (150 mg/mL/1%) 10 mL Multi-Dose Vial, For IM Injection Only, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3113-07
Manufacturer
US Compounding Inc
Affected units
439

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 Numbers: 20150705@13 BUD: 11/3/2015
  • 20151805@36 BUD: 11/14/2015

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 59 recalled by US Compounding Inc 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 59 products in this recall →