Severity
Critical
CriticalClass ITerminated
FDA Drug recall · Reported January 16, 2019
Ceftriaxone for Injection USP, 500 mg, packaged in a) one Single Use Vial (NDC 68180-622-01) and b) 10 Single Use Vials per box (NDC 68180-622-10); Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., 111 South Calvert Street, Baltimore, Maryland 21202; Manufactured by: Lupin Limited, Mandideep 462 046 INDIA.
Presence of Particulate Matter: Product complaints received of grey flecks, identified as shredded rubber particulate matter from the stopper observed in reconstituted vials.
Compiled from official public sources by the editorial team.
Verify with FDA Drug →
Lupin Pharmaceuticals Inc. recalled Ceftriaxone for Injection USP, 500 mg, packaged in a) one Single Use Vial (NDC 68180-622-… - a critical-severity action.
Ceftriaxone for Injection USP, 500 mg, packaged in a) one Single Use Vial (NDC 68180-622-… was recalled by Lupin Pharmaceuticals Inc. in January 16, 2019. Reason: Presence of Particulate Matter: Product complaints received of grey flecks, identified as shredded rubber par…. Check the official notice for the remedy. Verify recall #D-0356-2019 with the FDA Drug before acting.
The recall
Lupin Pharmaceuticals Inc. issued this critical-severity FDA Drug recall-Presence of Particulate Matter: Product complaints received of grey flecks, identified as shredded rubber par….
- Critical
- severity level
- Class I
- classification
- January 16, 2019
- reported
Sourced from official FDA Drug enforcement records. Verify recall #D-0356-2019 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Drug action (record #D-0356-2019) was formally reported on January 16, 2019, with the manufacturer initiating the action on December 20, 2018. It is classified under Critical severity (Class I), with a current status of Terminated. Lupin Pharmaceuticals Inc. is listed as the recalling firm, operating out of Baltimore, MD. Federal records list the affected scope as a) 8,000 vials; b) 32,045 boxes.
The documented reason for this recall is: Presence of Particulate Matter: Product complaints received of grey flecks, identified as shredded rubber particulate matter from the stopper observed in reconstituted vials. Distribution data in the federal record shows the product reached: Nationwide in the USA and Puerto Rico.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 5 from FDA Drug and 1 from Lupin Pharmaceuticals Inc. - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Drugs & Medications recalls over time
Where this recall sits in its category - 14,287 drugs & medications recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified high severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
a) 8,000 vials; b) 32,045 boxes
Related Recalls
6
5 from same agency
Product description
Ceftriaxone for Injection USP, 500 mg, packaged in a) one Single Use Vial (NDC 68180-622-01) and b) 10 Single Use Vials per box (NDC 68180-622-10); Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., 111 South Calvert Street, Baltimore, Maryland 21202; Manufactured by: Lupin Limited, Mandideep 462 046 INDIA.
Reason for recall
Presence of Particulate Matter: Product complaints received of grey flecks, identified as shredded rubber particulate matter from the stopper observed in reconstituted vials.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Critical (Class I) |
| Status | Terminated |
| Recall number | D-0356-2019 |
| Date reported | January 16, 2019 |
| Date initiated | December 20, 2018 |
| Recalling firm | Lupin Pharmaceuticals Inc. |
| Firm location | Baltimore, MD |
| Affected scope | a) 8,000 vials; b) 32,045 boxes |
| Distribution | Nationwide in the USA and Puerto Rico. |
Profile values are sourced directly from the official FDA Drug enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (D-0356-2019) and product description against the item you own. Search the archive
- Confirm the current status with FDA Drug before acting, recall details can be updated.
- This is a Class I (high-risk) recall, stop using the product immediately and follow the disposal or return instructions. What to do next
This page summarizes the official FDA Drug record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
Ceftriaxone for Injection USP, 500 mg, packaged in a) one Single Use Vial (NDC 68180-622-01) and b) 10 Single Use Vials per box (NDC 68180-622-10); Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., 111 South Calvert Street, Baltimore, Maryland 21202; Manufactured by: Lupin Limited, Mandideep 462 046 INDIA.. Recalled by Lupin Pharmaceuticals Inc.. Units affected: a) 8,000 vials; b) 32,045 boxes.
Why was this product recalled? ▼
Presence of Particulate Matter: Product complaints received of grey flecks, identified as shredded rubber particulate matter from the stopper observed in reconstituted vials.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on January 16, 2019. Severity: Critical. Recall number: D-0356-2019.
Where was the recalled product distributed? ▼
Distribution: Nationwide in the USA and Puerto Rico..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (D-0356-2019) against your product. Visit the official FDA Drug website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
Nearby Recalls in This Category
Other recalls in the same product category, useful for spotting patterns across the same defect class or manufacturer.
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fentaNYL Citrate, Sterile CADD for Injection, 2,2500 mcg/50mL in Sterile Water, IntegraDose Compounding Services LLC, 3…
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Liraglutide Injection, 18 mg/3 mL (6 mg/mL), Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Naples, FL 34108, …
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Compare this recall with PRED MILD, prednisolone acetate ophthalmic suspension, USP,… →
Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Drug, reported January 16, 2019. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.