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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 92341

52 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
May 15, 2023
Product types
Drug
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Astral SteriTech Private Ltd.

Dossier provenance

Source snapshots represented here

  • openFDA Drug Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

52 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

drug · product 1 of 52

Ampicillin for Injection, USP 250 mg per vial, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017 USA, NDC 66794-220-41

D-0580-2023
Recall number
D-0580-2023
Initiated
May 15, 2023
Classification
Class II
Status
Terminated
Quantity
70,040 vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All lots within expiry.

Distribution pattern

Nationwide within the United States

drug · product 2 of 52

Ampicillin for Injection, USP 500 mg per vial, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017 USA, NDC 66794-221-41

D-0581-2023
Recall number
D-0581-2023
Initiated
May 15, 2023
Classification
Class II
Status
Terminated
Quantity
17,350 vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All lots within expiry.

Distribution pattern

Nationwide within the United States

drug · product 3 of 52

Ampicillin for Injection, USP 1g per vial, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017 USA, NDC 66794-222-41

D-0582-2023
Recall number
D-0582-2023
Initiated
May 15, 2023
Classification
Class II
Status
Terminated
Quantity
89,690 vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All lots within expiry.

Distribution pattern

Nationwide within the United States

drug · product 4 of 52

Ampicillin for Injection, USP 2g per vial, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017 USA, NDC 66794-223-41

D-0583-2023
Recall number
D-0583-2023
Initiated
May 15, 2023
Classification
Class II
Status
Terminated
Quantity
45,160 vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All lots within expiry.

Distribution pattern

Nationwide within the United States

drug · product 5 of 52

Ampicillin for Injection, USP 10 g per Pharmacy Bulk Package, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017 USA, NDC 66794-224-15

D-0584-2023
Recall number
D-0584-2023
Initiated
May 15, 2023
Classification
Class II
Status
Terminated
Quantity
8,925 bottles

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All lots within expiry.

Distribution pattern

Nationwide within the United States

drug · product 6 of 52

Ampicillin for Injection, USP, 250 mg per vial, Rx only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089, NDC 70594-084-02

D-0585-2023
Recall number
D-0585-2023
Initiated
May 15, 2023
Classification
Class II
Status
Terminated
Quantity
53,220 vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All lots within expiry.

Distribution pattern

Nationwide within the United States

drug · product 7 of 52

Ampicillin for Injection, USP 500 mg per vial, Rx only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089, NDC 70594-085-02

D-0586-2023
Recall number
D-0586-2023
Initiated
May 15, 2023
Classification
Class II
Status
Terminated
Quantity
59,530 vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All lots within expiry.

Distribution pattern

Nationwide within the United States

drug · product 8 of 52

Ampicillin for Injection, USP 1g per vial, Rx only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089, NDC 70594-086-02

D-0587-2023
Recall number
D-0587-2023
Initiated
May 15, 2023
Classification
Class II
Status
Terminated
Quantity
80,850 vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All lots within expiry.

Distribution pattern

Nationwide within the United States

drug · product 9 of 52

Ampicillin for Injection, USP 2 g per vial, Rx only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089, NDC 70594-087-02

D-0588-2023
Recall number
D-0588-2023
Initiated
May 15, 2023
Classification
Class II
Status
Terminated
Quantity
220,340 vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All lots within expiry.

Distribution pattern

Nationwide within the United States

drug · product 10 of 52

Ampicillin for Injection, USP 10 grams per Pharmacy Bulk Package, Rx only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089, NDC 70594-088-01

D-0589-2023
Recall number
D-0589-2023
Initiated
May 15, 2023
Classification
Class II
Status
Terminated
Quantity
7,214 bottles

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All lots within expiry.

Distribution pattern

Nationwide within the United States

drug · product 11 of 52

Ampicillin and Sulbactam for Injection, USP 1.5 gram per vial, Rx only, Manufactured for: Civica Inc. Lehi Utah 84043, NDC 72572-021-10

D-0590-2023
Recall number
D-0590-2023
Initiated
May 15, 2023
Classification
Class II
Status
Terminated
Quantity
59,040 vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All lots within expiry.

Distribution pattern

Nationwide within the United States

drug · product 12 of 52

Ampicillin and Sulbactam for Injection, USP 3 gram per vial, Rx only, Manufactured for: Civica Inc. Lehi Utah 84043, NDC 72572-022-10

D-0591-2023
Recall number
D-0591-2023
Initiated
May 15, 2023
Classification
Class II
Status
Terminated
Quantity
419,680 vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All lots within expiry.

Distribution pattern

Nationwide within the United States

drug · product 13 of 52

Ampicillin and Sulbactam for Injection, USP 1.5 grams per vial, Rx only, Mfd for Meitheal Pharmaceuticals Chicago, IL 60631, NDC 71288-005-20

D-0592-2023
Recall number
D-0592-2023
Initiated
May 15, 2023
Classification
Class II
Status
Terminated
Quantity
236,610 vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All lots within expiry.

Distribution pattern

Nationwide within the United States

drug · product 14 of 52

Ampicillin and Sulbactam for Injection, USP 3 grams per vial, Rx only, Mfd for Meitheal Pharmaceuticals Chicago, IL 60631, NDC 71288-006-30

D-0593-2023
Recall number
D-0593-2023
Initiated
May 15, 2023
Classification
Class II
Status
Terminated
Quantity
1,229,090 vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All lots within expiry.

Distribution pattern

Nationwide within the United States

drug · product 15 of 52

Ampicillin and Sulbactam for Injection, USP 15 grams per Pharmacy Bulk Package, Rx only, Mfd for Meitheal Pharmaceuticals Chicago, IL 60631, NDC 71288-007-75

D-0594-2023
Recall number
D-0594-2023
Initiated
May 15, 2023
Classification
Class II
Status
Terminated
Quantity
35,087 bottles

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All lots within expiry.

Distribution pattern

Nationwide within the United States

drug · product 16 of 52

Ampicillin and Sulbactam for Injection, USP 1.5 grams per vial, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017 USA, NDC 66794-206-41

D-0595-2023
Recall number
D-0595-2023
Initiated
May 15, 2023
Classification
Class II
Status
Terminated
Quantity
357,550 vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All lots within expiry.

Distribution pattern

Nationwide within the United States

drug · product 17 of 52

Ampicillin and Sulbactam for Injection, USP 1.5 grams per vial, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017 USA, NDC 66794-241-41

D-0596-2023
Recall number
D-0596-2023
Initiated
May 15, 2023
Classification
Class II
Status
Terminated
Quantity
58,770 vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All lots within expiry.

Distribution pattern

Nationwide within the United States

drug · product 18 of 52

Ampicillin and Sulbactam for Injection, USP 3 grams per vial, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017 USA, NDC 66794-207-41

D-0597-2023
Recall number
D-0597-2023
Initiated
May 15, 2023
Classification
Class II
Status
Terminated
Quantity
1,001,110 vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All lots within expiry.

Distribution pattern

Nationwide within the United States

drug · product 19 of 52

Ampicillin and Sulbactam for Injection, USP 15 grams per Pharmacy Bulk Package, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017 USA, NDC 66794-208-15

D-0598-2023
Recall number
D-0598-2023
Initiated
May 15, 2023
Classification
Class II
Status
Terminated
Quantity
11,555 bottles

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All lots within expiry.

Distribution pattern

Nationwide within the United States

drug · product 20 of 52

Ampicillin and Sulbactam for Injection, USP 15 grams per Pharmacy Bulk Package, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017 USA, NDC 66794-243-15

D-0599-2023
Recall number
D-0599-2023
Initiated
May 15, 2023
Classification
Class II
Status
Terminated
Quantity
6,127 bottles

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All lots within expiry.

Distribution pattern

Nationwide within the United States

drug · product 21 of 52

Ampicillin and Sulbactam for Injection, USP 3 grams vials, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017 USA, NDC 66794-242-41

D-0600-2023
Recall number
D-0600-2023
Initiated
May 15, 2023
Classification
Class II
Status
Terminated
Quantity
91,860 vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All lots within expiry.

Distribution pattern

Nationwide within the United States

drug · product 22 of 52

Ampicillin and Sulbactam for Injection, USP 1.5 grams per vial, Rx only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089, NDC 70594-081-02

D-0601-2023
Recall number
D-0601-2023
Initiated
May 15, 2023
Classification
Class II
Status
Terminated
Quantity
119,340 vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All lots within expiry.

Distribution pattern

Nationwide within the United States

drug · product 23 of 52

Ampicillin and Sulbactam for Injection, USP 3 grams per vial, Rx only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089, NDC 70594-082-02

D-0602-2023
Recall number
D-0602-2023
Initiated
May 15, 2023
Classification
Class II
Status
Terminated
Quantity
591,160 vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All lots within expiry.

Distribution pattern

Nationwide within the United States

drug · product 24 of 52

Ampicillin and Sulbactam for Injection, USP 15 grams per Pharmacy Bulk Package, Rx only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089, NDC 70594-083-01

D-0603-2023
Recall number
D-0603-2023
Initiated
May 15, 2023
Classification
Class II
Status
Terminated
Quantity
23,187 bottles

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All lots within expiry.

Distribution pattern

Nationwide within the United States

drug · product 25 of 52

Cefepime for Injection, USP 1 gram per vial, Rx only, Manufactured for: Civica Inc. Lehi Utah 84043, NDC 72572-057-10

D-0604-2023
Recall number
D-0604-2023
Initiated
May 15, 2023
Classification
Class II
Status
Terminated
Quantity
101,550 vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All lots within expiry.

Distribution pattern

Nationwide within the United States

drug · product 26 of 52

Cefepime for Injection, USP 2 grams per vial, Rx only, Manufactured for: Civica Inc. Lehi Utah 84043, NDC 72572-058-10

D-0605-2023
Recall number
D-0605-2023
Initiated
May 15, 2023
Classification
Class II
Status
Terminated
Quantity
124,010 vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All lots within expiry.

Distribution pattern

Nationwide within the United States

drug · product 27 of 52

Cefepime for Injection, USP 2 grams per vial, Rx only, Mfd. for Meitheal Pharmaceuticals Chicago, IL 60631, NDC 71288-009-20

D-0606-2023
Recall number
D-0606-2023
Initiated
May 15, 2023
Classification
Class II
Status
Terminated
Quantity
107,320 vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All lots within expiry.

Distribution pattern

Nationwide within the United States

drug · product 28 of 52

Cefepime for Injection, USP 1 gram per vial, Rx only, Mfg. for: Piramal Critical Care Bethlehem, PA 18017 USA, NDC 66794-209-41

D-0607-2023
Recall number
D-0607-2023
Initiated
May 15, 2023
Classification
Class II
Status
Terminated
Quantity
41,320 vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All lots within expiry.

Distribution pattern

Nationwide within the United States

drug · product 29 of 52

Cefepime for Injection, USP 2 grams per vial, Rx only, Mfg. for: Piramal Critical Care Bethlehem, PA 18017 USA, NDC 66794-210-41

D-0608-2023
Recall number
D-0608-2023
Initiated
May 15, 2023
Classification
Class II
Status
Terminated
Quantity
51,280 vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All lots within expiry.

Distribution pattern

Nationwide within the United States

drug · product 30 of 52

Cefepime for Injection, USP 1 gram per vial, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089, NDC 70594-089-02

D-0609-2023
Recall number
D-0609-2023
Initiated
May 15, 2023
Classification
Class II
Status
Terminated
Quantity
550,160 vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All lots within expiry.

Distribution pattern

Nationwide within the United States

drug · product 31 of 52

Cefepime for Injection, USP 2 grams per vial, Rx only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089, NDC 70594-090-02

D-0610-2023
Recall number
D-0610-2023
Initiated
May 15, 2023
Classification
Class II
Status
Terminated
Quantity
964,420 vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All lots within expiry.

Distribution pattern

Nationwide within the United States

drug · product 32 of 52

Ceftriaxone for Injection, USP 250 mg per vial, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017, NDC 66794-211-42

D-0611-2023
Recall number
D-0611-2023
Initiated
May 15, 2023
Classification
Class II
Status
Terminated
Quantity
66,250 vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All lots within expiry.

Distribution pattern

Nationwide within the United States

drug · product 33 of 52

Ceftriaxone for Injection, USP 500 mg per vial, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017, NDC 66794-212-42

D-0612-2023
Recall number
D-0612-2023
Initiated
May 15, 2023
Classification
Class II
Status
Terminated
Quantity
65,950 vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All lots within expiry.

Distribution pattern

Nationwide within the United States

drug · product 34 of 52

Ceftriaxone for Injection, USP 1 gram per vial, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017, NDC 66794-213-42

D-0613-2023
Recall number
D-0613-2023
Initiated
May 15, 2023
Classification
Class II
Status
Terminated
Quantity
73,475 vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All lots within expiry.

Distribution pattern

Nationwide within the United States

drug · product 35 of 52

Ceftriaxone for Injection, USP 2 grams per vial, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017, NDC 66794-214-42

D-0614-2023
Recall number
D-0614-2023
Initiated
May 15, 2023
Classification
Class II
Status
Terminated
Quantity
41,500 vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All lots within expiry.

Distribution pattern

Nationwide within the United States

drug · product 36 of 52

Ceftriaxone for Injection, USP 10 grams per Pharmacy Bulk Package, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017, NDC 66794-215-15

D-0615-2023
Recall number
D-0615-2023
Initiated
May 15, 2023
Classification
Class II
Status
Terminated
Quantity
9,040 bottles

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All lots within expiry.

Distribution pattern

Nationwide within the United States

drug · product 37 of 52

Ceftriaxone for Injection, USP 250 mg per vial, Rx only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089, NDC 70594-094-02

D-0616-2023
Recall number
D-0616-2023
Initiated
May 15, 2023
Classification
Class II
Status
Terminated
Quantity
66,125 vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All lots within expiry.

Distribution pattern

Nationwide within the United States

drug · product 38 of 52

Ceftriaxone for Injection, USP 500 mg per vial, Rx only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089, NDC 70594-095-02

D-0617-2023
Recall number
D-0617-2023
Initiated
May 15, 2023
Classification
Class II
Status
Terminated
Quantity
66,175 vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All lots within expiry.

Distribution pattern

Nationwide within the United States

drug · product 39 of 52

Ceftriaxone for Injection, USP, 1 grams per vial, Rx only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089, NDC 70594-096-02

D-0618-2023
Recall number
D-0618-2023
Initiated
May 15, 2023
Classification
Class II
Status
Terminated
Quantity
739,750 vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All lots within expiry.

Distribution pattern

Nationwide within the United States

drug · product 40 of 52

Ceftriaxone for Injection, USP, 2 grams per vial, Rx only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089, NDC 70594-097-02

D-0619-2023
Recall number
D-0619-2023
Initiated
May 15, 2023
Classification
Class II
Status
Terminated
Quantity
243,825 vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All lots within expiry.

Distribution pattern

Nationwide within the United States

drug · product 41 of 52

Ceftriaxone for Injection, USP 10 grams per Pharmacy Bulk Package, Rx only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089, NDC 70594-098-01

D-0620-2023
Recall number
D-0620-2023
Initiated
May 15, 2023
Classification
Class II
Status
Terminated
Quantity
7,940 bottles

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All lots within expiry.

Distribution pattern

Nationwide within the United States

drug · product 42 of 52

Piperacillin and Tazobactam for Injection, USP, 3.375 grams per vial, Rx only, Manufactured for: Civica Inc. Lehi Utah 84043, NDC 72572-576-10

D-0621-2023
Recall number
D-0621-2023
Initiated
May 15, 2023
Classification
Class II
Status
Terminated
Quantity
1,288,510 vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All lots within expiry.

Distribution pattern

Nationwide within the United States

drug · product 43 of 52

Piperacillin and Tazobactam for Injection, USP, 4.5 grams per vial, Rx only, Manufactured for: Civica Inc. Lehi Utah 84043, NDC 72572-577-10

D-0622-2023
Recall number
D-0622-2023
Initiated
May 15, 2023
Classification
Class II
Status
Terminated
Quantity
204,860 vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All lots within expiry.

Distribution pattern

Nationwide within the United States

drug · product 44 of 52

Piperacillin and Tazobactam for Injection, USP, 2.25 grams per vial, Rx only, Mfd for Meitheal Pharmaceuticals Chicago, IL 60631, NDC 71288-002-31

D-0623-2023
Recall number
D-0623-2023
Initiated
May 15, 2023
Classification
Class II
Status
Terminated
Quantity
110,660 vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All lots within expiry.

Distribution pattern

Nationwide within the United States

drug · product 45 of 52

Piperacillin and Tazobactam for Injection, USP 3.375 grams per vial, Rx only, Mfd for Meitheal Pharmaceuticals Chicago, IL 60631, NDC 71288-003-31

D-0624-2023
Recall number
D-0624-2023
Initiated
May 15, 2023
Classification
Class II
Status
Terminated
Quantity
893,950 vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All lots within expiry.

Distribution pattern

Nationwide within the United States

drug · product 46 of 52

Piperacillin and Tazobactam for Injection, USP 4.5 grams per vial, Rx only, Mfd for Meitheal Pharmaceuticals Chicago, IL 60631, NDC 71288-004-51

D-0625-2023
Recall number
D-0625-2023
Initiated
May 15, 2023
Classification
Class II
Status
Terminated
Quantity
249,080 vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All lots within expiry.

Distribution pattern

Nationwide within the United States

drug · product 47 of 52

Piperacillin and Tazobactam for Injection, USP, 2.25 grams per vial, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017, NDC66794-216-41

D-0626-2023
Recall number
D-0626-2023
Initiated
May 15, 2023
Classification
Class II
Status
Terminated
Quantity
112,640 vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All lots within expiry.

Distribution pattern

Nationwide within the United States

drug · product 48 of 52

Piperacillin and Tazobactam for Injection, USP, 3.375 grams per vial, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017, NDC 66794-217-41

D-0627-2023
Recall number
D-0627-2023
Initiated
May 15, 2023
Classification
Class II
Status
Terminated
Quantity
223,590 vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All lots within expiry.

Distribution pattern

Nationwide within the United States

drug · product 49 of 52

Piperacillin and Tazobactam for Injection, USP, 4.5 grams per vial, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017, NDC 66794-218-41

D-0628-2023
Recall number
D-0628-2023
Initiated
May 15, 2023
Classification
Class II
Status
Terminated
Quantity
138,610 vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All lots within expiry.

Distribution pattern

Nationwide within the United States

drug · product 50 of 52

Piperacillin and Tazobactam for Injection, USP 2.25 g per vial,s Rx only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089, NDC 70594-078-02

D-0629-2023
Recall number
D-0629-2023
Initiated
May 15, 2023
Classification
Class II
Status
Terminated
Quantity
169,520 Vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All lots within expiry.

Distribution pattern

Nationwide within the United States

drug · product 51 of 52

Piperacillin and Tazobactam for Injection, UPS, 3.375 grams per vial, Rx only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089, NDC 70594-079-02

D-0630-2023
Recall number
D-0630-2023
Initiated
May 15, 2023
Classification
Class II
Status
Terminated
Quantity
936,680 vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All lots within expiry.

Distribution pattern

Nationwide within the United States

drug · product 52 of 52

Piperacillin and Tazobactam for Injection, USP, 4.5 grams per vial, Rx only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089, NDC 70594-080-02

D-0631-2023
Recall number
D-0631-2023
Initiated
May 15, 2023
Classification
Class II
Status
Terminated
Quantity
393,930 vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All lots within expiry.

Distribution pattern

Nationwide within the United States