Why it was recalled
Presence of Particulate Matter: Crystalline particles were noticed by manufacturer at the 24 month clarity testing.
Product description
GENTAMICIN OPTH-SOL 5ml Compare: Garamycin. 5-mL plastic dropper bottle, Mfg: AKORN 17478-0283-10. NDC 52959-0103-00
Lot numbers, UPCs & expiration codes
Lot # GNT01AK, Exp. 02/19 & GNT07AK, Exp. 3/20
Where it was sold
Nationwide in the USA and Puerto Rico
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0415-2019
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Oct 18, 2018
- FDA report date
- Feb 6, 2019
- Quantity
- 84, 5 ml bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- H J Harkins Company Inc dba Pharma Pac
Original FDA data
Every field from FDA enforcement report D-0415-2019, exactly as published.
Show all FDA fields
- City
- Grover Beach
- State
- CA
- Status
- Terminated
- Country
- United States
- Event ID
- 81343
- Address
- 1400 W Grand Ave Ste F
- Code information
- Lot # GNT01AK, Exp. 02/19 & GNT07AK, Exp. 3/20
- Postal code
- 93433-4221
- Report date
- Feb 6, 2019
- Product type
- Drugs
- Recall number
- D-0415-2019
- Classification
- Class II
- Recalling firm
- H J Harkins Company Inc dba Pharma Pac
- Product quantity
- 84, 5 ml bottles
- Termination date
- May 6, 2021
- Reason for recall
- Presence of Particulate Matter: Crystalline particles were noticed by manufacturer at the 24 month clarity testing.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- GENTAMICIN OPTH-SOL 5ml Compare: Garamycin. 5-mL plastic dropper bottle, Mfg: AKORN 17478-0283-10. NDC 52959-0103-00
- Distribution pattern
- Nationwide in the USA and Puerto Rico
- Recall initiation date
- Oct 18, 2018
- Initial firm notification
- Letter
- Center classification date
- Jan 28, 2019