Home / Recalls / RIJ Pharmaceutical LLC / D-0843-2018

D-0843-2018 Class II Terminated

Recalled by RIJ Pharmaceutical LLC — Middletown, NY

Recall Details

Product Type
Drugs
Report Date
June 20, 2018
Initiation Date
May 7, 2018
Termination Date
April 7, 2023
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
N/A

Product Description

Preferred Plus Pharmacy Antacid (Aluminum Hydroxide 200mg, Magnesium Hydroxide 200mg Simethicone 20mg, packaged in 12 FL. OZ. (355 mL) bottles, Manufactured By: RIJ PHARMACEUTICAL CORPORATION 40 Commercial Avenue Middletown, NY 10941, Distributed by: Kinray Inc. Whitestone, NY 11357, NDC 53807-12612, UPC 53807126122

Reason for Recall

CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbial count in a water sample.

Distribution Pattern

Nationwide in the USA

Code Information

Lot #: 707006, Exp. 07/19; 708001, Exp. 08/19

Other recalls by RIJ Pharmaceutical LLC

  • D-0845-2018 Class II — RPC Children's Non-Aspirin (Acetaminophen 160 mg) Elixir, packaged in 4 FL. OZ. (May 7, 2018)
  • D-0850-2018 Class II — Geritrex Senna Syrup (sennosides 8.8mg), packaged in 8 FL OZ. (236 mL) bottle, D (May 7, 2018)
  • D-0853-2018 Class II — Gericare Iron Supplement Elixir Ferrous Sulfate 220 mg, packaged in 16 fl oz. (4 (May 7, 2018)
  • D-0849-2018 Class II — Ritussin DM Dextromethorphan Hydrobormide (Dextromethorphan HBr, USP 10 mg, Guai (May 7, 2018)
  • D-0846-2018 Class II — Gericare Liquid Pain Relief Acetaminophen Cherry Flavor 160mg/5mL, packaged in 1 (May 7, 2018)
  • D-0842-2018 Class II — Preferred Plus Pharmacy Antacid Extra Strength (Aluminum Hydroxide 400mg, Magnes (May 7, 2018)
  • D-0847-2018 Class II — RPC APAP Elixir (Acetaminophen 160mg), Packaged in 16 FL. OZ. (473 mL) bottles, (May 7, 2018)
  • D-0844-2018 Class II — RPC Senna Syrup (Sennosides 8.8mg), packaged in 8 fl oz (237 mL) bottles, RIJ Ph (May 7, 2018)
  • D-0852-2018 Class II — Gericare Diocto Liquid (Docusate Sodium 50mg), 50 mg/5 mL, packaged in 16 FL OZ (May 7, 2018)
  • D-0851-2018 Class II — SDA Senna Syrup (Sennosides 8.8mg), packaged in 8 FL. OZ. (236 mL) bottles, Dist (May 7, 2018)