Recall events
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Event 90583
Event summary
Timeline bucket July 11, 2022
Product types Drug
Classifications Class II
Statuses Terminated
Recalling firm wording Hikma Pharmaceuticals USA Inc.
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
Device root-cause evidence is not applicable to this event.
No grouped product has the official product type device; this is not an unavailable-enrichment finding.
Complete imported group
Every recalled product in this event
4 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 4
Lorazepam Injection, USP, 2mg/mL, 1 mL vial, 25 vials per carton, RX Only, Manufactured by West-Ward Eatontown, NJ 07724, Carton NDC# 0641-6044-25, Vial NDC# 0641-6044-01
D-1307-2022
Recall number D-1307-2022
Initiated July 11, 2022
Classification Class II
Status Terminated
Quantity 4,739,000 vials
App-derived interpretation
Potency or specification failure
reason.potency_specification_failure · v1.0.0
Out-of-specification
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Failed Impurities/Degradation Specifications: Out-of-specification results observed for total related compounds during testing of retain samples.
Code information Lot # 060064, Exp. 06/2023, 070084, Exp. 07/2023, 070126, Exp. 07/2023, 080091, Exp. 08/2023, 080060, Exp. 08/2023
Distribution pattern Nationwide in the USA
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[5371]
FDA event record
· Exact recall-number query on openFDA
drug · product 2 of 4
Ativan Injection (lorazepam injection, USP), 2mg/mL, 1 mL vial, 25 vials per carton, RX Only, Manufactured by West-Ward Eatontown, NJ 07724, Carton NDC# 0641-6001-25, Vial NDC# 0641-6001-01
D-1308-2022
Recall number D-1308-2022
Initiated July 11, 2022
Classification Class II
Status Terminated
Quantity 301,400 vials
App-derived interpretation
Potency or specification failure
reason.potency_specification_failure · v1.0.0
Out-of-specification
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Failed Impurities/Degradation Specifications: Out-of-specification results observed for total related compounds during testing of retain samples.
Code information Lot # 060064Z, Exp. 06/2023
Distribution pattern Nationwide in the USA
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[4951]
FDA event record
· Exact recall-number query on openFDA
drug · product 3 of 4
Lorazepam Injection, USP, 2mg/mL, 1 mL vial, 25 vial per carton, Rx Only, Novaplus, Manufactured by Hikma Berkeley Heights, NJ 07922. Carton NDC# 0641-6048-25, Vial NDC# 0641-6048-01
D-1309-2022
Recall number D-1309-2022
Initiated July 11, 2022
Classification Class II
Status Terminated
Quantity 713,550 vials
App-derived interpretation
Potency or specification failure
reason.potency_specification_failure · v1.0.0
Out-of-specification
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Failed Impurities/Degradation Specifications: Out-of-specification results observed for total related compounds during testing of retain samples.
Code information Lot # 070088, exp. date 07/2023
Distribution pattern Nationwide in the USA
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[5377]
FDA event record
· Exact recall-number query on openFDA
drug · product 4 of 4
Lorazepam Injection, USP, 4mg/mL, 1 mL vial, 25 vial per carton, Rx Only, Novaplus, Manufactured by Hikma Berkeley Heights, NJ 07922. Carton NDC# NDC# 0641-6045-25, Vial NDC# 0641-6045-01
D-1310-2022
Recall number D-1310-2022
Initiated July 11, 2022
Classification Class II
Status Terminated
Quantity 82,700 vials
App-derived interpretation
Potency or specification failure
reason.potency_specification_failure · v1.0.0
Out-of-specification
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Failed Impurities/Degradation Specifications: Out-of-specification results observed for total related compounds during testing of retain samples.
Code information Lot # 070096, exp. date 07/2023
Distribution pattern Nationwide in the USA
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[5418]
FDA event record
· Exact recall-number query on openFDA
