The Recall Desk
SevereFDA (Drugs)·D-1391-2015·Announced 2015-09-02

Liberty Drug Recalls 17-Hydroxyprogesterone Injectable Due to Sterility Concerns

Liberty Drug & Surgical is recalling 85 vials of 17-Hydroxyprogesterone injectable because process deficiencies may have compromised 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: The recall is classified as FDA Class II and involves a risk of serious injury due to compromised sterility in an injectable product, meeting the criteria for a Severe rating.

Plain-English summary

Liberty Drug & Surgical is recalling 85 vials of 17-Hydroxyprogesterone 250 mg/mL Injectable, 5 mL multi-dose vial. The recall is due to process deficiencies observed in sterile ophthalmic and injectable products that could have compromised the sterility of the product.

The affected product was distributed to physicians, medical facilities, and prescription-specific patients in New Jersey and New York. The recall covers lot numbers 03182015@8 (expiration 07/31/15) and 05112015@7 (expiration 09/24/15).

Patients who have received this medication should contact their healthcare provider for further instructions. The FDA classifies this recall as Class II.

The recalled product

Product
17-Hydroxyprogesterone 250 mg/mL Injectable, 5 mL multi-dose vial, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ 07928.
Affected units
85

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 (4)

  • Lot #: 03182015@8
  • Exp 07/31/15
  • 05112015@7
  • Exp 09/24/15

Distribution

Distributed in 2 states:

Part of a larger recall action

This product is one of 25 recalled by Liberty Drug & Surgical 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 25 products in this recall →