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Medium RiskFDA Drug
Medications & Supplements/Prescription Drugs

Lupin Pharmaceuticals Inc.: Cefdinir Oral Suspension Recalled for Thick Texture and Formulation Defects

Agency Publication Date: January 9, 2019
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Summary

Lupin Pharmaceuticals Inc. has recalled 575,568 bottles of Cefdinir for Oral Suspension USP, a generic antibiotic used to treat bacterial infections. Approximately 287,784 bottles of the 125mg/5mL strength and 287,784 bottles of the 250mg/5mL strength are affected. The recall was initiated because the company received complaints that the medication became too thick after being mixed with water, which can lead to dosing inaccuracies or difficulty administering the drug. These products were distributed nationwide in 60mL and 100mL bottles and were available by prescription.

Risk

A thick or improperly formulated suspension can prevent the medication from being measured correctly, potentially leading to an underdose or overdose. If the drug is too thick to be poured or swallowed easily, the patient may not receive the full therapeutic dose required to treat their infection, potentially leading to treatment failure.

What You Should Do

  1. Check your prescription bottle for 'Cefdinir for Oral Suspension USP' in either 125mg/5mL or 250mg/5mL strengths.
  2. For 125mg/5mL (60mL or 100mL) bottles, verify if your lot number is: F700329, F700330, F700328, F700544, F700545, F700668, F700669, F700670, F700958, F700327, F700392, F700393, F700546, F700547, F700664, F700967, F701106, F701107, F701108, or F701109.
  3. For 250mg/5mL (60mL or 100mL) bottles, verify if your lot number is: F700343, F700344, F700345, F700346, F700347, F700376, F700377, F700415, F700146, F700417, F700418, F700419, F700420, F700492, F700493, F700508, F700665, F700784, F700324, F700325, F700326, F700618, F700619, or F700620.
  4. If your medication matches any of these lot numbers and expiration dates (ranging from January 2019 to May 2019), contact your healthcare provider or pharmacist immediately for guidance on a replacement.
  5. Return any unused portion of the recalled medication to the pharmacy where it was purchased for a refund.
  6. Contact Lupin Pharmaceuticals Inc. at their Baltimore office or via the contact methods provided by your pharmacist for further instructions regarding this recall.
  7. For additional questions, contact the FDA Consumer Complaint line at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

๐Ÿ’ฐFull Refund

Return for refund and consult healthcare provider

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: Cefdinir for Oral Suspension USP, 125mg/5mL (60mL)
Model:
NDC 68180-722-20
D-0375-2019
Lot Numbers:
F700329 (Exp. January 2019)
F700330 (Exp. January 2019)
F700328 (Exp. January 2019)
F700544 (Exp. March 2019)
F700545 (Exp. March 2019)
F700668 (Exp. March 2019)
F700669 (Exp. March 2019)
F700670 (Exp. March 2019)
F700958 (Exp. April 2019)
Date Ranges: January 2019, March 2019, April 2019
Product: Cefdinir for Oral Suspension USP, 125mg/5mL (100mL)
Model:
NDC 68180-722-10
D-0375-2019
Lot Numbers:
F700327 (Exp. January 2019)
F700392 (Exp. January 2019)
F700393 (Exp. January 2019)
F700546 (Exp. March 2019)
F700547 (Exp. March 2019)
F700664 (Exp. March 2019)
F700967 (Exp. April 2019)
F701106 (Exp. May 2019)
F701107 (Exp. May 2019)
F701108 (Exp. May 2019)
F701109 (Exp. May 2019)
Date Ranges: January 2019, March 2019, April 2019, May 2019
Product: Cefdinir for Oral Suspension USP, 250mg/5mL (60mL)
Model:
NDC 68180-723-20
D-0376-2019
Lot Numbers:
F700343 (Exp. January 2019)
F700344 (Exp. January 2019)
F700345 (Exp. January 2019)
F700346 (Exp. January 2019)
F700347 (Exp. January 2019)
F700376 (Exp. January 2019)
F700377 (Exp. January 2019)
F700415 (Exp. January 2019)
F700146 (Exp. January 2019)
F700417 (Exp. January 2019)
F700418 (Exp. January 2019)
F700419 (Exp. February 2019)
F700420 (Exp. February 2019)
F700492 (Exp. February 2019)
F700493 (Exp. February 2019)
F700508 (Exp. February 2019)
F700665 (Exp. February 2019)
F700784 (Exp. April 2019)
Date Ranges: January 2019, February 2019, April 2019
Product: Cefdinir for Oral Suspension USP, 250mg/5mL (100mL)
Model:
NDC 68180-723-10
D-0376-2019
Lot Numbers:
F700324 (Exp. January 2019)
F700325 (Exp. January 2019)
F700326 (Exp. January 2019)
F700618 (Exp. February 2019)
F700619 (Exp. February 2019)
F700620 (Exp. February 2019)
Date Ranges: January 2019, February 2019

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 81888
Status: Resolved
Manufacturer: Lupin Pharmaceuticals Inc.
Sold By: Pharmacies
Manufactured In: India, United States
Units Affected: 2 products (287,784 bottles)
Distributed To: Nationwide
Agency Last Updated: January 15, 2019

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.