Class II · Moderate risk Ongoing
Children's Ibuprofen Oral Suspension
Reason Presence of foreign substance: the firm received complaints for a gel-like mass and black particles in the product.
PD-Rx Pharmaceuticals Incorporated Ibuprofen 200 mg tablets a) 24…
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
CGMP deviations.
What was recalled
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
- Recalling firm
- PD-Rx Pharmaceuticals, Inc.
- NDC code
- 55289-673-24
- Origin
- OK, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0341-2018
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Other Ibuprofen recalls
See all
Class II · Moderate risk Ongoing
Advil a) Ibuprofen
Reason CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
Class II · Moderate risk Ongoing
Acetaminophen and Ibuprofen
Reason CGMP Deviations
Class III · Low risk Ongoing
IBU (ibuprofen) 600 mg tablets, 500-count bottle, Rx Only…
Reason Failed Tablet/Capsule Specifications
Class II · Moderate risk Ongoing
Ibuprofen 800mg
Reason Failed Impurities/Degradation Specifications: Product failed impurity specifications at the 18-month stability testing.
Get an alert if your medication is recalled
Tell us which medications you take. If the FDA recalls one, we email you - in plain English, with what to do. Free.