Gentamicin Opth-sol recall: Particulate Matter
GENTAMICIN OPTH-SOL 5ml Compare: Garamycin. 5-mL plastic dropper bottle, Mfg: AKORN 17478-0283-10. NDC 52959-0103-00
Why was Gentamicin Opth-sol recalled?
Presence of Particulate Matter: Crystalline particles were noticed by manufacturer at the 24 month clarity testing.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot # GNT01AK, Exp. 02/19 & GNT07AK, Exp. 3/20
- Product
- GENTAMICIN OPTH-SOL 5ml Compare: Garamycin. 5-mL plastic dropper bottle, Mfg: AKORN 17478-0283-10. NDC 52959-0103-00
- Recalling firm
- H J Harkins Company Inc dba Pharma Pac
- Quantity
- 84, 5 ml bottles
- Distribution
- Nationwide in the USA and Puerto Rico
- Recall date
- February 6, 2019
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)