The Recall Desk
ModerateFDA (Drugs)·D-1060-2016·Announced 2016-07-06

Actavis Recalls Ciprofloxacin Ophthalmic Solution Due to Impurity

Actavis Pharma Inc. is voluntarily recalling Ciprofloxacin Ophthalmic Solution due to out-of-specification results for an unknown impurity near expiration.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class III, which the rubric associates with scores of 1 or 2. Given the presence of an unknown impurity, a score of 2 (Moderate) is appropriate as it is a voluntary precautionary recall for a potential quality issue rather than a cosmetic or documentation-only defect.

Plain-English summary

Actavis Pharma Inc. is voluntarily recalling Ciprofloxacin Ophthalmic Solution (0.3% as base), sterile, prescription only, in 2.5 mL, 5 mL, and 10 mL bottles. The recall was initiated due to out-of-specification results for an unknown impurity at or near the 24-month expiration date.

The affected product is manufactured by Hi-Tech Pharmacal Co. Inc. and distributed nationwide and in Puerto Rico. The recall covers 447,150 bottles across multiple lot numbers and expiration dates ranging from March 2016 to October 2017.

Consumers and healthcare providers should stop using the recalled product and contact their pharmacist or healthcare provider for a replacement or refund. The FDA classifies this recall as Class III, indicating that use of or exposure to the product is not likely to cause adverse health consequences.

The recalled product

Product
Ciprofloxacin Ophthalmic Solution (0.3% as base), Sterile, Rx only, a) 2.5 mL Bottle, b) 5 mL Bottle, c) 10 mL Bottle, For Topical Ophthalmic Use Only, Hi-Tech Pharmacal Co. Inc., Amityville, NY 11701, NDC: a) 50383-0282-02, b) 50383-282-05, c) 50383-0282-10
Manufacturer
Actavis Pharma Inc
Category
Drug — Ophthalmic Solution
Hazard
Affected units
447,150

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 (20)

  • Lot #s: a) 626487
  • Exp. 3/31/2016
  • 628181
  • Exp. 6/30/2016
  • 629827
  • Exp. 9/30/2016
  • 630495
  • Exp. 10/31/2016
  • 632266
  • Exp. 2/28/2017
  • 633683 Exp. 4/30/2017
  • 347742
  • Exp. 09/30/2017
  • b) 626487
  • 627438
  • 628080
  • Exp. 5/31/2016
  • 628491
  • 628634
  • Exp. 7/31/2016

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

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