Home / Recalls / H J Harkins Company Inc dba Pharma Pac / D-1246-2020

D-1246-2020 Class II Terminated

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

Recall Details

Product Type: Drugs
Report Date: April 22, 2020
Initiation Date: April 15, 2020
Termination Date: February 14, 2024
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 9,000 tablets

Product Description

Acetaminophen and Codeine Phosphate 300/30 mg tablet, packaged in: a) 10-count bottle (NDC 52959-0003-10), b) 12-count bottle (NDC 52959-0003-12), c) 14-count bottle (NDC 52959-0003-14), d) 15-count bottle (NDC 52959-0003-15), e) 16-count bottle (NDC 52959-0003-16), f) 20-count bottle (NDC 52959-0003-20), g) 30-count bottle (NDC 52959-0003-30), h) 60-count bottle (NDC 52959-0003-60), Rx Only, Mfg. Aurobindo; Repack: H.J. Harkins Co., Inc., Grover Beach, CA 93433

Reason for Recall

cGMP Deviations

Distribution Pattern

Product was distributed in CA and AZ.

Code Information

Lot # ATP12ZT, Exp. 05/21

Other recalls by H J Harkins Company Inc dba Pharma Pac

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-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)