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Recall Observatory FDA recall evidence

Drug product

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

D-0843-2018

May 07, 2018

Class II

Product summary

Firm
RIJ Pharmaceutical LLC
Event
Event 80053
Status
Terminated
Classification
Class II
Quantity
N/A
Official record key
drug-enforcement:D-0843-2018

Official wording

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

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

Distribution pattern: Nationwide in the USA

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    CGMP Deviations
  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    out of specification

Field note

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