Class II · Moderate risk
Children's Ibuprofen Oral Suspension
Presence of foreign substance: the firm received complaints for a gel-like mass and black particles in the product.
Ibuprofen Tablets
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies.
Cause type: cGMP deviation
Departures from current Good Manufacturing Practice found in production or during FDA inspection. A broad quality-system cause: the batch was made under conditions that fall short of FDA manufacturing standards. All cgmp deviation recalls.
What was recalled
Ibuprofen Tablets, USP 600 mg, 6 x 2500 Tablets bulk packed in double polybag shipper packs for further packaging, Rx only, Manufactured by: Marksans Pharma Ltd., Plot No. L-82, L-83, Verna Indl. Estate, Verna, Goa - 403 722, India, NDC 25000-122-28.
Affected NDC
25000-0122-28
Compare with the code on your package — it is the most precise check available.
Drug: Ibuprofen Category: Pain Relief & OTC Medication
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Ibuprofen NDC 25000-0122 |
600 mg/1 | Tablet Oral |
Marksans Pharma Limited | Rx |
- Recalling firm
- Marksans Pharma Inc.
- NDC code
- 25000-122-28
- Origin
- NY, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0239-2018 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Ibuprofen recalls
See all
Class II · Moderate risk
Advil a) Ibuprofen
CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
Class II · Moderate risk
Acetaminophen and Ibuprofen
CGMP Deviations
Class III · Low risk
IBU (ibuprofen)
Failed Tablet/Capsule Specifications
Class II · Moderate risk
Ibuprofen 800mg
Failed Impurities/Degradation Specifications: Product failed impurity specifications at the 18-month stability testing.
Other recalls by Marksans Pharma Inc.
All 2018 recalls
Class II · Moderate risk
Time-Cap Labs
CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Class II · Moderate risk
Time-Cap Labs
CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Class II · Moderate risk
Time-Cap Labs
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Class II · Moderate risk
Ibuprofen Tablets
CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies.
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