The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1390-2015·Announced 2015-09-02

Liberty Drug Recalls Doxycycline IV Bags Due to Sterility Concerns

Liberty Drug & Surgical is recalling 58 bags of Doxycycline IV solution because process deficiencies may have compromised sterility.

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 and involves a lack of assurance of sterility in an injectable product, which poses a significant risk of infection or serious injury.

Plain-English summary

Liberty Drug & Surgical is recalling 58 bags of Doxycycline/0.9 % NaCl 100 mg/100 mL IV solution. The recall was initiated because process deficiencies were observed in the sterile ophthalmic and injectable products, which could have compromised the sterility of the product.

The affected product is distributed to physicians, medical facilities, and prescription-specific patients in New Jersey and New York. The specific lot numbers involved are 05142015@21, 05192015@22, 05282015@16, 06022015@18, and 06102015@16, all with an expiration date of 07/06/15.

Healthcare providers and patients should stop using the recalled product and contact Liberty Drug & Surgical for further instructions.

The recalled product

Product
Doxycycline/0.9 % NaCl 100 mg/100 mL IV, 100 mL bag, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ 07928.
Affected units
58

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 (6)

  • Lot #: 05142015@21
  • 05192015@22
  • 05282015@16
  • 06022015@18
  • 06102015@16
  • Exp 07/06/15

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 →

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