Home / Recalls / Heritage Pharmaceuticals, Inc. / D-1397-2019

D-1397-2019 Class I Terminated

Recalled by Heritage Pharmaceuticals, Inc. — East Brunswick, NJ

Recall Details

Product Type
Drugs
Report Date
June 19, 2019
Initiation Date
May 21, 2019
Termination Date
January 11, 2022
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
55,480 2 mL vials

Product Description

PROCHLORPERAZINE EDISYLATE INJECTION, USP 10 mg/2mL (5mg/mL), 2mL Vial, Rx Only, Mfg by: Emcure Pharmaceuticals Ltd., Hinjawadi, Pune, India. Mfg for: Heritage Pharmaceuticals Inc. NDC 23155-294-31

Reason for Recall

Non-Sterility:Microbial growth detected in sub lot of Amikacin Sulfate Injection, USP 1gm/4 mL (250mg/mL) and Prochlorperazine Edisylate Injection, USP 10mg/2mL (5mg/mL) .

Distribution Pattern

Nationwide in the USA

Code Information

Lot: VPCA172, EXP April 2020

Other recalls by Heritage Pharmaceuticals, Inc.

  • D-0111-2026 Class II — Desipramine Hydrochloride Tablets, USP, 100 mg, 100 count bottle (NDC 23155-582- (October 6, 2025)
  • D-0112-2026 Class II — Desipramine Hydrochloride Tablets, USP, 150 mg, 50 count bottle (NDC 23155-583-2 (October 6, 2025)
  • D-0109-2026 Class II — Desipramine Hydrochloride Tablets, USP, 50 mg, 100 count bottle (NDC 23155-580-0 (October 6, 2025)
  • D-0108-2026 Class II — Desipramine Hydrochloride Tablets, USP, 25 mg, 100 count bottle (NDC 23155-579-0 (October 6, 2025)
  • D-0107-2026 Class II — Desipramine Hydrochloride Tablets, USP, 10 mg, 100 - count bottle (NDC 23155-578 (October 6, 2025)
  • D-0110-2026 Class II — Desipramine Hydrochloride Tablets, USP, 75 mg, 100 count bottle (NDC 23155-581-0 (October 6, 2025)
  • D-0072-2023 Class II — Desmopressin Acetate Tablets 0.2mg, 100-count bottles, RX Only, Distributed by: (November 23, 2022)
  • D-0367-2021 Class III — Acyclovir Tablets, USP, 400 mg, 100 Tablets, Rx Only, Distributed by: Avet Pharm (April 21, 2021)
  • D-0108-2021 Class III — Felodipine Extended Release Tablets, USP 10 mg,100-count bottle, Rx only, Distri (October 23, 2020)
  • D-1398-2019 Class I — AMIKACIN SULFATE INJECTION, USP, 1 gram/4 mL (250 mg/ml), 4 mL vial, Rx only, Mf (May 21, 2019)