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, 200 mg, a) 50 tablet (NDC 53943-291-15), b) 100 tablet (NDC 53943-291-12), c) 500 tablet (NDC 53943-291-14), Brown, Distributed by Drug Mart, Food Fair, Medina, Ohio 44256
Affected NDCs
53943-0291-12
53943-0291-14
53943-0291-15
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 53943-0291 |
200 mg/1 | Tablet, Film Coated Oral |
Discount Drug Mart | OTC |
- Recalling firm
- Time-Cap Laboratories, Inc.
- NDC code
- 53943-291-15
- Origin
- NY, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0686-2018 · 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 Time-Cap Laboratories, Inc.
All 2018 recalls
Class II · Moderate risk
Ibuprofen Caplets USP 200 mg
CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies.
Class II · Moderate risk
Ibuprofen Caplets USP 200 mg
CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies.
Class II · Moderate risk
Ibuprofen Tablets USP 800 mg
CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies.
Class II · Moderate risk
Ibuprofen Tablets USP 800 mg
CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies.
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