Home / Recalls / H J Harkins Company Inc dba Pharma Pac / D-0415-2019

D-0415-2019 Class II Terminated

Recalled by H J Harkins Company Inc dba Pharma Pac — Grover Beach, CA

Recall Details

Product Type
Drugs
Report Date
February 6, 2019
Initiation Date
October 18, 2018
Termination Date
May 6, 2021
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
84, 5 ml bottles

Product Description

GENTAMICIN OPTH-SOL 5ml Compare: Garamycin. 5-mL plastic dropper bottle, Mfg: AKORN 17478-0283-10. NDC 52959-0103-00

Reason for Recall

Presence of Particulate Matter: Crystalline particles were noticed by manufacturer at the 24 month clarity testing.

Distribution Pattern

Nationwide in the USA and Puerto Rico

Code Information

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

Other recalls by H J Harkins Company Inc dba Pharma Pac

  • D-1246-2020 Class II — Acetaminophen and Codeine Phosphate 300/30 mg tablet, packaged in: a) 10-count b (April 15, 2020)
  • D-1005-2020 Class II — Acetaminophen 500 mg tablet packaged in a) 30-count bottles ( NDC 52959-0002-30) (March 6, 2020)
  • D-0793-2020 Class II — Ranitidine, 150 mg Tablets, a) 7 count, b) 14 count, c) 20 count, d) 30 count, e (January 6, 2020)
  • D-1580-2019 Class II — Neomycin 3.5 mg/g / Polymyxin B10000 USP Units/g / Dexamethasone 1 mg/g Ophthalm (July 12, 2019)
  • D-1430-2019 Class II — Diphenhydramine HCL Liquid, 12.5 mg/5 mL, 4 oz bottle, Manufactured by Torrent P (June 24, 2019)
  • D-1429-2019 Class II — Acetaminophen Children's Liquid, 160 mg/5 mL, 4 oz bottle, Manufactured by Torre (June 24, 2019)
  • D-1083-2019 Class II — Losartan Potassium 100 mg Tablets # 30 Losartan potassium tablets USP, 100 mg a (March 4, 2019)
  • D-1022-2018 Class II — Valsartan tablets 160 mg, 90-count bottle, Rx Only, Repackaged by H.J. Harkins C (July 26, 2018)