The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0561-2016·Announced 2016-01-13

PD-Rx Pharmaceuticals Recalls Azithromycin 500 mg Tablets for cGMP Deviations

PD-Rx Pharmaceuticals is recalling Azithromycin 500 mg tablets because the original manufacturer did not adequately investigate customer complaints, resulting in cGMP deviations.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, which is a reasonable probability of temporary or medically reversible adverse health consequences. The specific issue is a cGMP deviation regarding the investigation of customer complaints, which is a quality control failure rather than a direct, reported physical hazard like contamination or mislabeling of a common allergen.

Plain-English summary

PD-Rx Pharmaceuticals, Inc. is recalling Azithromycin 500 mg tablets, prescription only, packaged in 1, 2, 3, and 7 count bottles. The product was manufactured by Wokhardt Ltd. in Mumbai, India, and packaged by PD-Rx Pharmaceuticals in Oklahoma City, Oklahoma. A total of 17,533 bottles were distributed nationwide.

The recall is the result of cGMP (Current Good Manufacturing Practice) deviations. Specifically, the original manufacturer did not adequately investigate customer complaints. This failure to investigate complaints constitutes a deviation from required manufacturing and quality control standards.

Consumers and healthcare providers should stop using the affected Azithromycin 500 mg tablets and return them to the pharmacy or point of purchase. The affected lots include specific lot numbers and expiration dates ranging from October 2014 to December 2015, as detailed in the recall notice.

The recalled product

Product
Azithromycin 500 mg tablets, Rx Only, packaged in a) 1 count, b) 2 count, c) 3 count, and d) 7 count bottles, Packaged by: PD-RX Pharmaceuticals, Inc., Oklahoma City, OK 73127, Mfr: Wokhardt Ltd., Mumbai, India, NDC: a) 55289-274-79, b) 55289-274-02, c) 55289-274-03, d)…
Manufacturer
PD-Rx Pharmaceuticals, Inc.
Category
Drug — Antibiotic
Hazard
Affected units
17,533

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • Lot #s: J12C03
  • J12D19
  • Exp 10/14
  • L12B52
  • L12E79
  • L12G92
  • Exp 12/14
  • A13G14
  • A13H49
  • Exp 01/15
  • B13G53
  • Exp 02/15
  • D13A66
  • Exp 04/15
  • E13E35
  • Exp 05/15
  • F13A58
  • F13D85
  • F13F17
  • F13F27

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by PD-Rx Pharmaceuticals, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

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