The Recall Desk
ModerateFDA (Drugs)·D-0415-2019·Announced 2019-02-06

Gentamicin Ophthalmic Solution Recalled for Crystalline Particulate Matter

H J Harkins Company is recalling Gentamicin Ophthalmic Solution due to crystalline particles found during clarity testing.

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 II, and the hazard involves particulate matter in an ophthalmic solution without reported injuries or illnesses, fitting the criteria for a moderate severity recall.

Plain-English summary

H J Harkins Company Inc dba Pharma Pac is recalling 84 bottles of Gentamicin Ophthalmic Solution, 5 mL. The product is identified by NDC 52959-0103-00 and was distributed nationwide in the USA and Puerto Rico.

The recall was initiated because crystalline particles were noticed by the manufacturer during 24-month clarity testing. The affected lots are GNT01AK with an expiration date of 02/19 and GNT07AK with an expiration date of 3/20.

Consumers should stop using the recalled product and contact their healthcare provider or pharmacist for instructions on how to dispose of the medication or obtain a replacement.

The recalled product

Product
GENTAMICIN OPTH-SOL 5ml Compare: Garamycin. 5-mL plastic dropper bottle, Mfg: AKORN 17478-0283-10. NDC 52959-0103-00
Manufacturer
H J Harkins Company Inc dba Pharma Pac
Category
Drug — Ophthalmic
Hazard

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 (3)

  • Lot # GNT01AK
  • Exp. 02/19 & GNT07AK
  • Exp. 3/20

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Related recalls

Same manufacturer · H J Harkins Company Inc dba Pharma Pac

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Same hazard · particulate matter

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