The Recall Desk
ModerateFDA (Drugs)·D-0560-2016·Announced 2016-01-13

PD-Rx Recalls Azithromycin Tablets Due to Inadequate Complaint Investigation

PD-Rx Pharmaceuticals is recalling 45,022 bottles of Azithromycin Tablets, USP, 250 mg, because the manufacturer did not adequately investigate customer complaints.

What this means for you

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. The source text cites a cGMP deviation regarding complaint investigation without reporting specific illnesses or injuries, which aligns with the 'Moderate' severity criteria for voluntary precautionary or low-risk contamination issues where harm is not explicitly reported.

Plain-English summary

PD-Rx Pharmaceuticals, Inc. is recalling 45,022 bottles of Azithromycin Tablets, USP, 250 mg, Rx Only. The product is packaged in 2-count and 4-count bottles and was distributed nationwide. The tablets were manufactured by Wockhardt Ltd. in Mumbai, India, and packaged by PD-Rx Pharmaceuticals in Oklahoma City, OK.

The recall is the result of the original manufacturer's recall, which was initiated because the firm did not adequately investigate customer complaints. This constitutes a cGMP (Current Good Manufacturing Practice) deviation. The source text does not report any specific illnesses, injuries, or deaths associated with this recall.

Consumers who have these products should contact their healthcare provider or pharmacist for guidance. The affected NDCs are 55289-964-02 and 55289-964-04. Specific lot numbers and expiration dates are listed in the official recall notice.

The recalled product

Product
Azithromycin Tablets, USP, 250 mg, Rx Only, packaged in a) 2 count and b) 4 count bottles, Packaged by: PD-RX Pharmaceuticals, Inc., Oklahoma City, OK, 73127, Mfg: Wockhardt Ltd., Mumbai, India, NDC: a) 55289-964-02, b) 55289-964-04.
Manufacturer
PD-Rx Pharmaceuticals, Inc.
Category
Drug — Antibiotic
Hazard
Affected units
45,022

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: a) J12A48
  • Exp 10/14
  • L12A23
  • Exp 12/14
  • A13G04
  • A13H14
  • Exp 01/15
  • B13E97
  • Exp 02/15
  • C13B55
  • Exp 03/15
  • J13F75
  • L13C93
  • A14F78
  • A14H17
  • B14A6
  • Exp 08/15
  • I13D47
  • I13G28
  • Exp 09/15

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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Same hazard · cGMP deviation

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