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.
Ibu (NDC 55111-684-05) (Ibuprofen)
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Labeling: Incorrect or missing lot and/or exp date- This product is being recalled due to an incorrect expiration date of 05/2017. The correct expiration date is 10/2016.
Cause type: Labeling / mix-up
Wrong label, wrong strength, mixed-up products, or packaging errors. One of the most dangerous causes - you can end up taking the wrong drug or the wrong dose. All labeling / mix-up recalls.
What was recalled
IBU (TM) IBUPROFEN Tablets, USP, 800 mg, 500 -count bottle,(NDC 55111-684-05) Rx only, Distributed by Dr. Reddy's Laboratories, Inc., Bridgewater, NJ 08807 USA.
Affected NDC
55111-0684-05
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 |
|---|---|---|---|---|
| Ibu Ibuprofen NDC 55111-0684 |
800 mg/1 | Tablet Oral |
Dr. Reddy's Laboratories Limited | Rx |
- Recalling firm
- Dr. Reddy's Laboratories, Inc.
- NDC code
- 55111-684-05
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1042-2013 · 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 Dr. Reddy's Laboratories, Inc.
All 2013 recalls
Class III · Low risk
Varenicline Tablets
Sub potent drug: during the 9-month stability test conducted, the assay value for the affected lot was below specification limit.
Class II · Moderate risk
Succinylcholine Chloride Injection
Out-of-Specification (OOS) result during the 6-month stability testing; decreased preservative concentration.
Class II · Moderate risk
Omeprazole Delayed-release Capsules
Presence of foreign tablets/capsules: presence of foreign Divalproex Sodium Extended-Release 250mg tablet in a bottle of omeprazole capsules.
Class I · High risk
Levetiracetam 0.75% in Sodium Chloride Injection 1
LABELING: LABEL MIX-UP: The infusion bag is incorrectly labeled as Levetiracetam in 0.82% Sodium Chloride Injection 500 mg/100 mL, while the aluminum overwrap packaging correctly identifies the product as Levetiracetam in 0.75% Sodium Chloride Injection 1,000 mg/100 mL.
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