Recall events
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Event 68191
Event summary
Timeline bucket April 21, 2014
Product types Drug
Classifications Class I and Class II
Statuses Terminated
Recalling firm wording Pharmakon Pharmaceuticals
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
Midazolam HCl 2 mg/ml in 0.9% Sodium Chloride in 30 mL PVC Vial, Rx Only. Pharmakon Pharmaceuticals, Inc., 14450 Getz Rd., Noblesville IN 46060 NDC#: 45183-0234-68.
D-1565-2014
Recall number D-1565-2014
Initiated April 21, 2014
Classification Class I
Status Terminated
Quantity 20 vials
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Incorrect/ Undeclared Excipient: Contains undeclared benzyl alcohol.
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Incorrect/ Undeclared Excipient: Contains undeclared benzyl alcohol.
Code information Lot #: E21294K3C Exp Date: 6/29/2014
Distribution pattern United States: TX, IL, MD, IN
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[5793]
FDA event record
· Exact recall-number query on openFDA
drug · product 2 of 4
Midazolam HCl 1 mg/ml in 0.9% Sodium Chloride in 50 mL and 100 mL IV bag, Rx Only. Labeled A) 50 mL, Pharmakon Pharmaceuticals, Inc., 14450 Getz Rd., Noblesville, IN 46060. NDC#: 45183-0989-41. B) 100 mL, Pharmakon Pharmaceuticals, 14450 Getz Rd., Noblesville, IN 888-660-6715. NDC#: 45183-0796-48.
D-1566-2014
Recall number D-1566-2014
Initiated April 21, 2014
Classification Class I
Status Terminated
Quantity 10/50 mL bags, 40/100 mL bags
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Incorrect/ Undeclared Excipient: Contains undeclared benzyl alcohol.
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Incorrect/ Undeclared Excipient: Contains undeclared benzyl alcohol.
Code information A) Lot #: E21294DK1C; Exp Date: 05/22/2014 B) Lot #: E21294DK3C; Exp Date: 06/08/2014
Distribution pattern United States: TX, IL, MD, IN
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[7726]
FDA event record
· Exact recall-number query on openFDA
drug · product 3 of 4
Glycopyrrolate 0.2 mg/ml, 5 mL pre-filled syringe, Rx Only. Pharmakon Pharmaceuticals, Inc., 14450 Getz Rd., Noblesville, IN 46060, NDC#: 45183-0965-70.
D-1567-2014
Recall number D-1567-2014
Initiated April 21, 2014
Classification Class II
Status Terminated
Quantity 200 Syringes
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Incorrect/ Undeclared Excipient: Contains undeclared benzyl alcohol.
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Incorrect/ Undeclared Excipient: Contains undeclared benzyl alcohol.
Code information Lot #: E131210.212 Exp: 07/14/2014
Distribution pattern United States: TX, IL, MD, IN
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[7672]
FDA event record
· Exact recall-number query on openFDA
drug · product 4 of 4
Atropine Sulfate 0.4 mg/ml Injection, USP, Total Dosage 0.8 mg per 2 mL, 3 mL pre-filled syringe, Rx Only. Pharmakon Pharmaceuticals, Inc., 14450 Getz Road, Noblesville, IN. NDC: 45183-0105-78.
D-1568-2014
Recall number D-1568-2014
Initiated April 21, 2014
Classification Class I
Status Terminated
Quantity 5 Syringes
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Incorrect/ Undeclared Excipient: Contains undeclared benzyl alcohol.
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Incorrect/ Undeclared Excipient: Contains undeclared benzyl alcohol.
Code information Lot #: E0333282R; Exp: 7/13/2014
Distribution pattern United States: TX, IL, MD, IN
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[7498]
FDA event record
· Exact recall-number query on openFDA
