Class II · Moderate risk
Cefdinir for Oral Suspension USP
Defective container: lack of seal integrity.
Cefdinir for Oral Suspension USP
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Complaint received of metal piece identified in the product bottle prior to the reconstitution.
Cause type: Particulate / foreign matter
Visible foreign particles - glass, metal, fibers or other material - found in the product. Particles can enter from equipment wear, containers or the process, and are dangerous in injectables. All particulate / foreign matter recalls.
What was recalled
Cefdinir for Oral Suspension USP, 250mg/5mL, Powder for oral suspension, 60 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 20201, Manufactured by: Lupin Limited, Mandideep 462 046 India. NDC 68180-723-20
Affected NDC
68180-0723-20
Compare with the code on your package — it is the most precise check available.
Drug: Cefdinir
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 |
|---|---|---|---|---|
| Cefdinir NDC 68180-0723 |
250 mg/5mL | Powder, for Suspension Oral |
Lupin Pharmaceuticals, Inc. | Rx |
- Recalling firm
- Lupin Pharmaceuticals Inc.
- NDC code
- 68180-723-20
- Origin
- MD, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1320-2019 · 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 Cefdinir recalls
See all
Class II · Moderate risk
Cefdinir for Oral Suspension USP 125 mg/5 mL
Presence of foreign substance: Product complaint of foreign material in reconstituted bottle.
Class II · Moderate risk
Cefdinir for Oral Suspension USP 250 mg/5 mL
Presence of foreign substance: Product complaint of foreign material in reconstituted bottle.
Class II · Moderate risk
Cefdinir for Oral Suspension USP
Superpotent Drug: Out-of-specification (OOS) result observed in an assay test of retention samples.
Class III · Low risk
Cefdinir for Oral Suspension USP
Presence of Foreign substance: identified as a dead ant.
Other recalls by Lupin Pharmaceuticals Inc.
All 2019 recalls
Class II · Moderate risk
Clobetasol Propionate Cream USP
Failed content uniformity specifications.
Class II · Moderate risk
Glucagon Emergency Kit for Low Blood Sugar
CGMP deviation: OOS result observed for the Gliding Force functionality test during 12-month long term stability testing.
Class II · Moderate risk
prednisoLONE Acetate Ophthalmic Suspension
Presence of Foreign Substance
Class II · Moderate risk
Liraglutide Injection
Presence of particulate matter: a white thread-like structure in the cartridge
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