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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Drug
Medications & Supplements/Prescription Drugs

Aurobindo Pharma USA Inc.: Prescription Medications Recalled for Manufacturing Issues and Water Leakage

Agency Publication Date: April 13, 2020
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Summary

Aurobindo Pharma USA Inc. is recalling 210,520 units of various prescription medications, including Acetaminophen/Codeine, Gabapentin, Simvastatin, and Mirtazapine, due to a manufacturing defect. These products were produced in an area where water leakage was observed, which violates Good Manufacturing Practice (CGMP) standards and may compromise the safety or quality of the medicine. Consumers should check their medicine cabinets for the specific lot numbers and expiration dates listed and contact their healthcare provider for guidance on alternative medications.

Risk

Manufacturing drugs in a facility with active water leakage introduces a significant risk of microbial contamination or degradation of the active ingredients. This can lead to decreased effectiveness of the medication or potential infection, especially for patients with weakened immune systems.

What You Should Do

  1. Check your prescription bottles for the following medications and lot numbers: Acetaminophen and Codeine Phosphate (Lots 058180015A, 058180016A, 05818017B1, 059180023A, 059180024A, 059180025A, 060180017A, 060180019B1, 060180020A, 060180021A), Gabapentin (Lots 198180048A, 198180061A, 19819017A1), Levetiracetam (Lot 24719001A1), Simvastatin (Lot 05319004A1), Mirtazapine (Lot 031180028A), Phentermine (Lot 105180004A), or Oxycodone/Acetaminophen (Lot 046180056A).
  2. Verify the National Drug Code (NDC) on the label matches any of these affected numbers: 13107-058-01, 13107-059-99, 13107-060-01, 65862-198-99, 65862-247-08, 65862-053-90, 13107-031-34, 13107-105-01, or 13107-046-01.
  3. If your medication is part of this recall, contact your healthcare provider or pharmacist immediately to obtain a replacement prescription before you stop taking the medication.
  4. Return any unused portions of the recalled medication to your pharmacy for a refund and contact Aurobindo Pharma USA Inc. for further instructions.
  5. For additional questions or to report a problem, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

๐Ÿ’ฐFull Refund

Contact healthcare provider and return product for refund.

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

Affected Products

Product: Acetaminophen and Codeine Phosphate Tablets, USP, 300 mg/15 mg (100-count bottles)
Model:
NDC 13107-058-01
D-1229-2020
Lot Numbers:
058180015A (Exp. 07/2021)
058180016A (Exp. 07/2021)
05818017B1 (Exp. 09/2021)
Product: Acetaminophen and Codeine Phosphate Tablets, USP, 300 mg/30 mg (100-count bottles)
Model:
NDC 13107-059-99
D-1230-2020
Lot Numbers:
059180023A (Exp. 05/2021)
059180024A (Exp. 05/2021)
059180025A (Exp. 05/2021)
Product: Acetaminophen and Codeine Phosphate Tablets, USP, 300 mg/60 mg (100-count bottles)
Model:
NDC 13107-060-01
D-1231-2020
Lot Numbers:
060180017A (Exp. 06/2021)
060180019B1 (Exp. 06/2021)
060180020A (Exp. 06/2021)
060180021A (Exp. 06/2021)
Product: Gabapentin Capsules, USP 100mg (1,000-count bottles)
Model:
NDC 65862-198-99
D-1232-2020
Lot Numbers:
198180048A (Exp. 04/2021)
198180061A (Exp. 06/2020)
19819017A1 (Exp. 02/2021)
Product: Levetiracetam Tablets USP 750 mg (120-count bottles)
Model:
NDC 65862-247-08
D-1233-2020
Lot Numbers:
24719001A1 (Exp. 03/2021)
Product: Simvastatin Tablets, USP 40mg (90-count bottles)
Model:
NDC 65862-053-90
D-1234-2020
Lot Numbers:
05319004A1 (Exp. 03/2022)
Product: Mirtazapine Tablets, USP 15mg (30-count bottles)
Model:
NDC 13107-031-34
D-1235-2020
Lot Numbers:
031180028A (Exp. 03/2021)
Product: Phentermine Hydrochloride Capsules, USP 15mg (100-count bottles)
Model:
NDC 13107-105-01
D-1236-2020
Lot Numbers:
105180004A (Exp. 03/2020)
Product: Oxycodone and Acetaminophen Tablets, USP 10 mg/325 mg (100-count bottles)
Model:
NDC 13107-046-01
D-1237-2020
Lot Numbers:
046180056A (Exp. 05/2020)

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 85183
Status: Resolved
Manufacturer: Aurobindo Pharma USA Inc.
Sold By: Pharmacies
Manufactured In: United States
Units Affected: 9 products (14194 units; 4332 units; 57337 units; 26625 units; 8040 units; 26976 units; 56208 units; 2101 units; 14707 units)
Distributed To: Nationwide
Agency Last Updated: April 22, 2020

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.