H J Harkins Company Inc dba Pharma Pac
FDA Regulatory Profile
Summary
- Total Recalls
- 9
- 510(k) Clearances
- 0
- Inspections
- 5
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| D-1246-2020 | Class II | Acetaminophen and Codeine Phosphate 300/30 mg tablet, packaged in: a) 10-count bottle (NDC 52959-000 | April 15, 2020 |
| D-1005-2020 | Class II | Acetaminophen 500 mg tablet packaged in a) 30-count bottles ( NDC 52959-0002-30), b) 42-count bottle | 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) 60 count; Rx, Only | January 6, 2020 |
| D-1580-2019 | Class II | Neomycin 3.5 mg/g / Polymyxin B10000 USP Units/g / Dexamethasone 1 mg/g Ophthalmic Ointment, 3.5 g t | July 12, 2019 |
| D-1430-2019 | Class II | Diphenhydramine HCL Liquid, 12.5 mg/5 mL, 4 oz bottle, Manufactured by Torrent Pharma, Inc., Levitto | June 24, 2019 |
| D-1429-2019 | Class II | Acetaminophen Children's Liquid, 160 mg/5 mL, 4 oz bottle, Manufactured by Torrent Pharma, Inc., Lev | June 24, 2019 |
| D-1083-2019 | Class II | Losartan Potassium 100 mg Tablets # 30 Losartan potassium tablets USP, 100 mg are white to off whit | March 4, 2019 |
| D-0415-2019 | Class II | GENTAMICIN OPTH-SOL 5ml Compare: Garamycin. 5-mL plastic dropper bottle, Mfg: AKORN 17478-0283-10. | October 18, 2018 |
| D-1022-2018 | Class II | Valsartan tablets 160 mg, 90-count bottle, Rx Only, Repackaged by H.J. Harkins Co, Inc. Grover Beach | July 26, 2018 |