Home / Recalls / H J Harkins Company Inc dba Pharma Pac / D-1083-2019

D-1083-2019 Class II Terminated

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

Recall Details

Product Type
Drugs
Report Date
April 17, 2019
Initiation Date
March 4, 2019
Termination Date
May 24, 2023
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
300 tablets

Product Description

Losartan Potassium 100 mg Tablets # 30 Losartan potassium tablets USP, 100 mg are white to off white, film coated, tear drop shaped tablets, debossed with "H" on one side and "145" on the other side.

Reason for Recall

CGMP Deviations:Traces amounts of N-Nitroso N-Methyl 4- amino butyric acid (NMBA) impurity found in Active Pharmaceutical Ingredient (API).

Distribution Pattern

Product was distributed to a physician's office in California.

Code Information

Pharma Pac NDC: 76519-1033-03, Pharma Pac Lot # LTO00EW, Exp. 11/19, MFG NDC 31722-0702-30, MFG Lot # LOP17087, Exp. 11/2019.

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-0415-2019 Class II — GENTAMICIN OPTH-SOL 5ml Compare: Garamycin. 5-mL plastic dropper bottle, Mfg: A (October 18, 2018)
  • D-1022-2018 Class II — Valsartan tablets 160 mg, 90-count bottle, Rx Only, Repackaged by H.J. Harkins C (July 26, 2018)