The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0341-2018·Announced 2018-02-07

PD-Rx Recalls Ibuprofen 200 mg Tablets Due to Manufacturing Deviations

PD-Rx Pharmaceuticals is voluntarily recalling 7,174 bottles of Ibuprofen 200 mg tablets nationwide due to Current Good Manufacturing Practice (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 due to CGMP deviations, which fits the rubric for moderate severity involving voluntary precautionary recalls or minor labeling/manufacturing errors without reported serious injuries.

Plain-English summary

PD-Rx Pharmaceuticals, Inc. is voluntarily recalling 7,174 bottles of Ibuprofen 200 mg tablets. The affected products are available in 24, 30, 50, and 60-tablet bottle sizes with NDC numbers 55289-673-24, 55289-673-30, 55289-673-50, and 55289-673-60, respectively. The recall was initiated on January 25, 2018, and the products were distributed nationwide.

The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. The FDA classified this recall as Class II, which indicates a situation in which there is a reasonable probability that the 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. Specific lot numbers and expiration dates for the affected products are listed in the recall documentation.

Consumers who have purchased these specific lots of Ibuprofen 200 mg tablets should stop using them and contact their pharmacist or the recalling firm for instructions on how to return the product. The recall status is currently terminated.

The recalled product

Product
PD-Rx Pharmaceuticals Incorporated Ibuprofen 200 mg tablets a) 24 tablets NDC 55289-673-24; b) 30 tablets NDC 55289-673-30; c) 50 tablets NDC 55289-673-50; d) 60 tablets NDC 55289-673-60
Manufacturer
PD-Rx Pharmaceuticals, Inc.
Category
Drug — Ibuprofen
Hazard
Affected units
7,174

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 (13)

  • Lots: K16E92 Exp. 5/31/18
  • B17A87 Exp. 5/31/18
  • E17A51 Exp. 5/31/18
  • L16B59 Exp. 1/31/18
  • K16E01 Exp. 5/31/18
  • A17F21 Exp. 5/31/18
  • B17D71 Exp. 5/31/18
  • D17E92 Exp. 5/31/18
  • J16D13 Exp. 1/31/18
  • A17D63 Exp. 5/31/18
  • E17A18 Exp. 5/31/18
  • F17B87 Exp. 5/31/18
  • C17C58 Exp. 5/31/18

Distribution

Distributed nationwide across the United States.

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