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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

Civica, Meitheal, Piramal, and Xellia Antibiotics Recalled for Sterility Issues

Agency Publication Date: May 18, 2023
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Summary

Astral SteriTech Private Ltd. has recalled approximately 12,934,605 units of various injectable antibiotics, including Ampicillin, Cefepime, Ceftriaxone, and Piperacillin and Tazobactam, because of a lack of assurance of sterility. These prescription medications are administered by injection, and products that are not sterile can cause life-threatening infections or other severe health complications. The recall covers products manufactured for several pharmaceutical companies including Civica Inc., Meitheal Pharmaceuticals, Piramal Critical Care, and Xellia Pharmaceuticals. These drugs were distributed nationwide to hospitals, pharmacies, and healthcare providers.

Risk

Injecting a drug that is not sterile can introduce bacteria or other pathogens directly into the bloodstream or tissue, which could lead to serious infection or sepsis. No incidents or injuries have been reported to date.

What You Should Do

  1. This recall affects various injectable antibiotics including Ampicillin, Cefepime, Ceftriaxone, and Piperacillin/Tazobactam sold under the Civica, Meitheal, Piramal Critical Care, and Xellia Pharmaceuticals brands.
  2. Identify affected products by checking the drug name, manufacturer, and National Drug Code (NDC) printed on the vial or pharmacy bulk package label.
  3. Check the NDC numbers against the 52 affected codes, including NDC 70594-088-01, 72572-021-10, 71288-005-20, and 66794-206-41. See the Affected Products section below for the full list of affected codes.
  4. All lots of the listed products that are currently within their expiration dates are included in this recall.
  5. Stop using the recalled product immediately and quarantine all remaining stock to prevent further administration to patients.
  6. Contact the manufacturer, Astral SteriTech, or your medication distributor directly to arrange for the return of the recalled product.
  7. If you have health concerns or believe you have experienced an adverse reaction, contact your healthcare provider or pharmacist immediately.
  8. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions regarding this recall.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled product. Contact the manufacturer or your distributor to arrange return.

Affected Products

Product: Ampicillin for Injection, USP (10 grams per Pharmacy Bulk Package)by Xellia Pharmaceuticals USA, LLC
Variants: 10 grams, Pharmacy Bulk Package
Lot Numbers:
All lots within expiry
NDC:
70594-088-01

Recall #: D-0589-2023

Product: Ampicillin and Sulbactam for Injection, USP (1.5 gram per vial)by Civica Inc.
Variants: 1.5 gram, Vial
Lot Numbers:
All lots within expiry
NDC:
72572-021-10

Recall #: D-0590-2023

Product: Ampicillin and Sulbactam for Injection, USP (3 gram per vial)by Civica Inc.
Variants: 3 gram, Vial
Lot Numbers:
All lots within expiry
NDC:
72572-022-10

Recall #: D-0591-2023

Product: Ampicillin and Sulbactam for Injection, USP (1.5 grams per vial)by Meitheal Pharmaceuticals
Variants: 1.5 grams, Vial
Lot Numbers:
All lots within expiry
NDC:
71288-005-20

Recall #: D-0592-2023

Product: Ampicillin and Sulbactam for Injection, USP (3 grams per vial)by Meitheal Pharmaceuticals
Variants: 3 grams, Vial
Lot Numbers:
All lots within expiry
NDC:
71288-006-30

Recall #: D-0593-2023

Product: Ampicillin and Sulbactam for Injection, USP (15 grams per Pharmacy Bulk Package)by Meitheal Pharmaceuticals
Variants: 15 grams, Pharmacy Bulk Package
Lot Numbers:
All lots within expiry
NDC:
71288-007-75

Recall #: D-0594-2023

Product: Ampicillin and Sulbactam for Injection, USP (1.5 grams per vial)by Piramal Critical Care
Variants: 1.5 grams, Vial
Lot Numbers:
All lots within expiry
NDC:
66794-206-41

Recall #: D-0595-2023

Product: Ampicillin and Sulbactam for Injection, USP (1.5 grams per vial)by Piramal Critical Care
Variants: 1.5 grams, Vial
Lot Numbers:
All lots within expiry
NDC:
66794-241-41

Recall #: D-0596-2023

Product: Ampicillin and Sulbactam for Injection, USP (3 grams per vial)by Piramal Critical Care
Variants: 3 grams, Vial
Lot Numbers:
All lots within expiry
NDC:
66794-207-41

Recall #: D-0597-2023

Product: Ampicillin and Sulbactam for Injection, USP (15 grams per Pharmacy Bulk Package)by Piramal Critical Care
Variants: 15 grams, Pharmacy Bulk Package
Lot Numbers:
All lots within expiry
NDC:
66794-208-15

Recall #: D-0598-2023

Product: Ampicillin and Sulbactam for Injection, USP (15 grams per Pharmacy Bulk Package)by Piramal Critical Care
Variants: 15 grams, Pharmacy Bulk Package
Lot Numbers:
All lots within expiry
NDC:
66794-243-15

Recall #: D-0599-2023

Product: Ampicillin and Sulbactam for Injection, USP (3 grams per vial)by Piramal Critical Care
Variants: 3 grams, Vial
Lot Numbers:
All lots within expiry
NDC:
66794-242-41

Recall #: D-0600-2023

Product: Ampicillin and Sulbactam for Injection, USP (1.5 grams per vial)by Xellia Pharmaceuticals USA, LLC
Variants: 1.5 grams, Vial
Lot Numbers:
All lots within expiry
NDC:
70594-081-02

Recall #: D-0601-2023

Product: Ampicillin and Sulbactam for Injection, USP (3 grams per vial)by Xellia Pharmaceuticals USA, LLC
Variants: 3 grams, Vial
Lot Numbers:
All lots within expiry
NDC:
70594-082-02

Recall #: D-0602-2023

Product: Ampicillin and Sulbactam for Injection, USP (15 grams per Pharmacy Bulk Package)by Xellia Pharmaceuticals USA, LLC
Variants: 15 grams, Pharmacy Bulk Package
Lot Numbers:
All lots within expiry
NDC:
70594-083-01

Recall #: D-0603-2023

Product: Cefepime for Injection, USP (1 gram per vial)by Civica Inc.
Variants: 1 gram, Vial
Lot Numbers:
All lots within expiry
NDC:
72572-057-10

Recall #: D-0604-2023

Product: Cefepime for Injection, USP (2 grams per vial)by Civica Inc.
Variants: 2 grams, Vial
Lot Numbers:
All lots within expiry
NDC:
72572-058-10

Recall #: D-0605-2023

Product: Cefepime for Injection, USP (2 grams per vial)by Meitheal Pharmaceuticals
Variants: 2 grams, Vial
Lot Numbers:
All lots within expiry
NDC:
71288-009-20

Recall #: D-0606-2023

Product: Cefepime for Injection, USP (1 gram per vial)by Piramal Critical Care
Variants: 1 gram, Vial
Lot Numbers:
All lots within expiry
NDC:
66794-209-41

Recall #: D-0607-2023

Product: Cefepime for Injection, USP (2 grams per vial)by Piramal Critical Care
Variants: 2 grams, Vial
Lot Numbers:
All lots within expiry
NDC:
66794-210-41

Recall #: D-0608-2023

Product: Cefepime for Injection, USP (1 gram per vial)by Xellia Pharmaceuticals USA, LLC
Variants: 1 gram, Vial
Lot Numbers:
All lots within expiry
NDC:
70594-089-02

Recall #: D-0609-2023

Product: Cefepime for Injection, USP (2 grams per vial)by Xellia Pharmaceuticals USA, LLC
Variants: 2 grams, Vial
Lot Numbers:
All lots within expiry
NDC:
70594-090-02

Recall #: D-0610-2023

Product: Ceftriaxone for Injection, USP (250 mg per vial)by Piramal Critical Care
Variants: 250 mg, Vial
Lot Numbers:
All lots within expiry
NDC:
66794-211-42

Recall #: D-0611-2023

Product: Ceftriaxone for Injection, USP (500 mg per vial)by Piramal Critical Care
Variants: 500 mg, Vial
Lot Numbers:
All lots within expiry
NDC:
66794-212-42

Recall #: D-0612-2023

Product: Ceftriaxone for Injection, USP (1 gram per vial)by Piramal Critical Care
Variants: 1 gram, Vial
Lot Numbers:
All lots within expiry
NDC:
66794-213-42

Recall #: D-0613-2023

Product: Ceftriaxone for Injection, USP (2 grams per vial)by Piramal Critical Care
Variants: 2 grams, Vial
Lot Numbers:
All lots within expiry
NDC:
66794-214-42

Recall #: D-0614-2023

Product: Ceftriaxone for Injection, USP (10 grams per Pharmacy Bulk Package)by Piramal Critical Care
Variants: 10 grams, Pharmacy Bulk Package
Lot Numbers:
All lots within expiry
NDC:
66794-215-15

Recall #: D-0615-2023

Product: Ceftriaxone for Injection, USP (250 mg per vial)by Xellia Pharmaceuticals USA, LLC
Variants: 250 mg, Vial
Lot Numbers:
All lots within expiry
NDC:
70594-094-02

Recall #: D-0616-2023

Product: Ceftriaxone for Injection, USP (500 mg per vial)by Xellia Pharmaceuticals USA, LLC
Variants: 500 mg, Vial
Lot Numbers:
All lots within expiry
NDC:
70594-095-02

Recall #: D-0617-2023

Product: Ceftriaxone for Injection, USP (1 grams per vial)by Xellia Pharmaceuticals USA, LLC
Variants: 1 grams, Vial
Lot Numbers:
All lots within expiry
NDC:
70594-096-02

Recall #: D-0618-2023

Product: Ceftriaxone for Injection, USP (2 grams per vial)by Xellia Pharmaceuticals USA, LLC
Variants: 2 grams, Vial
Lot Numbers:
All lots within expiry
NDC:
70594-097-02

Recall #: D-0619-2023

Product: Ceftriaxone for Injection, USP (10 grams per Pharmacy Bulk Package)by Xellia Pharmaceuticals USA, LLC
Variants: 10 grams, Pharmacy Bulk Package
Lot Numbers:
All lots within expiry
NDC:
70594-098-01

Recall #: D-0620-2023

Product: Piperacillin and Tazobactam for Injection, USP (3.375 grams per vial)by Civica Inc.
Variants: 3.375 grams, Vial
Lot Numbers:
All lots within expiry
NDC:
72572-576-10

Recall #: D-0621-2023

Product: Piperacillin and Tazobactam for Injection, USP (4.5 grams per vial)by Civica Inc.
Variants: 4.5 grams, Vial
Lot Numbers:
All lots within expiry
NDC:
72572-577-10

Recall #: D-0622-2023

Product: Piperacillin and Tazobactam for Injection, USP (2.25 grams per vial)by Meitheal Pharmaceuticals
Variants: 2.25 grams, Vial
Lot Numbers:
All lots within expiry
NDC:
71288-002-31

Recall #: D-0623-2023

Product: Piperacillin and Tazobactam for Injection, USP (3.375 grams per vial)by Meitheal Pharmaceuticals
Variants: 3.375 grams, Vial
Lot Numbers:
All lots within expiry
NDC:
71288-003-31

Recall #: D-0624-2023

Product: Piperacillin and Tazobactam for Injection, USP (4.5 grams per vial)by Meitheal Pharmaceuticals
Variants: 4.5 grams, Vial
Lot Numbers:
All lots within expiry
NDC:
71288-004-51

Recall #: D-0625-2023

Product: Piperacillin and Tazobactam for Injection, USP (2.25 grams per vial)by Piramal Critical Care
Variants: 2.25 grams, Vial
Lot Numbers:
All lots within expiry
NDC:
66794-216-41

Recall #: D-0626-2023

Product: Piperacillin and Tazobactam for Injection, USP (3.375 grams per vial)by Piramal Critical Care
Variants: 3.375 grams, Vial
Lot Numbers:
All lots within expiry
NDC:
66794-217-41

Recall #: D-0627-2023

Product: Piperacillin and Tazobactam for Injection, USP (4.5 grams per vial)by Piramal Critical Care
Variants: 4.5 grams, Vial
Lot Numbers:
All lots within expiry
NDC:
66794-218-41

Recall #: D-0628-2023

Product: Piperacillin and Tazobactam for Injection, USP (2.25 g per vial)by Xellia Pharmaceuticals USA, LLC
Variants: 2.25 g, Vial
Lot Numbers:
All lots within expiry
NDC:
70594-078-02

Recall #: D-0629-2023

Product: Piperacillin and Tazobactam for Injection, UPS (3.375 grams per vial)by Xellia Pharmaceuticals USA, LLC
Variants: 3.375 grams, Vial
Lot Numbers:
All lots within expiry
NDC:
70594-079-02

Recall #: D-0630-2023

Product: Piperacillin and Tazobactam for Injection, USP (4.5 grams per vial)by Xellia Pharmaceuticals USA, LLC
Variants: 4.5 grams, Vial
Lot Numbers:
All lots within expiry
NDC:
70594-080-02

Recall #: D-0631-2023

Product: Ampicillin for Injection, USP (2 g per vial)by Xellia Pharmaceuticals USA, LLC
Variants: 2 g, Vial
Lot Numbers:
All lots within expiry
NDC:
70594-087-02

Recall #: D-0588-2023

Product: Ampicillin for Injection, USP (1g per vial)by Xellia Pharmaceuticals USA, LLC
Variants: 1g, Vial
Lot Numbers:
All lots within expiry
NDC:
70594-086-02

Recall #: D-0587-2023

Product: Ampicillin for Injection, USP (250 mg per vial)by Piramal Critical Care
Variants: 250 mg, Vial
Lot Numbers:
All lots within expiry
NDC:
66794-220-41

Recall #: D-0580-2023

Product: Ampicillin for Injection, USP (500 mg per vial)by Piramal Critical Care
Variants: 500 mg, Vial
Lot Numbers:
All lots within expiry
NDC:
66794-221-41

Recall #: D-0581-2023

Product: Ampicillin for Injection, USP (1g per vial)by Piramal Critical Care
Variants: 1g, Vial
Lot Numbers:
All lots within expiry
NDC:
66794-222-41

Recall #: D-0582-2023

Product: Ampicillin for Injection, USP (2g per vial)by Piramal Critical Care
Variants: 2g, Vial
Lot Numbers:
All lots within expiry
NDC:
66794-223-41

Recall #: D-0583-2023

Product: Ampicillin for Injection, USP (10 g per Pharmacy Bulk Package)by Piramal Critical Care
Variants: 10 g, Pharmacy Bulk Package
Lot Numbers:
All lots within expiry
NDC:
66794-224-15

Recall #: D-0584-2023

Product: Ampicillin for Injection, USP (250 mg per vial)by Xellia Pharmaceuticals USA, LLC
Variants: 250 mg, Vial
Lot Numbers:
All lots within expiry
NDC:
70594-084-02

Recall #: D-0585-2023

Product: Ampicillin for Injection, USP (500 mg per vial)by Xellia Pharmaceuticals USA, LLC
Variants: 500 mg, Vial
Lot Numbers:
All lots within expiry
NDC:
70594-085-02

Recall #: D-0586-2023

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 92341
Status: Resolved
Manufacturer: Astral SteriTech Private Ltd.
Sold By: Hospitals; Pharmacies; Healthcare Providers
Manufactured In: India
Units Affected: 52 products (70,040 vials; 17,350 vials; 89,690 vials; 45,160 vials; 8,925 bottles; 53,220 vials; 59,530 vials; 80,850 vials; 220,340 vials; 7,214 bottles; 59,040 vials; 419,680 vials; 236,610 vials; 1,229,090 vials; 35,087 bottles; 357,550 vials; 58,770 vials; 1,001,110 vials; 11,555 bottles; 6,127 bottles; 91,860 vials; 119,340 vials; 591,160 vials; 23,187 bottles; 101,550 vials; 124,010 vials; 107,320 vials; 41,320 vials; 51,280 vials; 550,160 vials; 964,420 vials; 66,250 vials; 65,950 vials; 73,475 vials; 41,500 vials; 9,040 bottles; 66,125 vials; 66,175 vials; 739,750 vials; 243,825 vials; 7,940 bottles; 1,288,510 vials; 204,860 vials; 110,660 vials; 893,950 vials; 249,080 vials; 112,640 vials; 223,590 vials; 138,610 vials; 169,520 Vials; 936,680 vials; 393,930 vials)
Distributed To: Nationwide

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.