Recall events
/
Event 78553
Event summary
Timeline bucket November 16, 2017
Product types Drug
Classifications Class II
Statuses Terminated
Recalling firm wording KRS Global Biotechnology, 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
47 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 47
Anastrozole 0.5 mg Capsules, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
D-0161-2018
Recall number D-0161-2018
Initiated November 16, 2017
Classification Class II
Status Terminated
Quantity 15,700 capsules
App-derived interpretation
Labeling or packaging
reason.labeling_packaging · v1.0.0
Labeling: Incorrect or Missing
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.
Code information Lots: 03092017@21 BUD: 3/9/2018; 03292017@33 BUD: 3/24/2018; 05092017@38 BUD: 5/4/2018; 05162017@31 BUD: 5/11/2018; 05182017@25 BUD: 5/13/2018; 07032017@40 BUD: 6/28/2018; 07142017@34 BUD: 7/9/2018; 07192017@32 BUD: 7/14/2018; 08282017@25 BUD: 8/23/2018; 09142017@8BUD: 9/9/2018; 09212017@23 BUD: 9/16/2018; 09272017@36 BUD: 9/ 22/2018; 10162017@39 BUD: 10/11/2018; 11032017@28 BUD: 10/29/2018
Distribution pattern Nationwide in the USA, Bermuda, and New Zealand
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[9655]
FDA event record
· Exact recall-number query on openFDA
drug · product 2 of 47
Amphotericin 60 mg/Chloramphenicol 600 mg/Hydrocortisone 10 mg Otic Powder packaged in jars, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
D-0162-2018
Recall number D-0162-2018
Initiated November 16, 2017
Classification Class II
Status Terminated
Quantity 80 vials
App-derived interpretation
Labeling or packaging
reason.labeling_packaging · v1.0.0
Labeling: Incorrect or Missing
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.
Code information Lot: 07282017@25 BUD: 1/24/2018
Distribution pattern Nationwide in the USA, Bermuda, and New Zealand
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[10023]
FDA event record
· Exact recall-number query on openFDA
drug · product 3 of 47
Anastrozole SR 1 mg Capsules, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
D-0163-2018
Recall number D-0163-2018
Initiated November 16, 2017
Classification Class II
Status Terminated
Quantity 22,520 capsules
App-derived interpretation
Labeling or packaging
reason.labeling_packaging · v1.0.0
Labeling: Incorrect or Missing
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.
Code information Lots: 02022017@30 BUD: 1/28/2018; 04172017@29 BUD: 4/12/2018; 05082017@39 BUD: 5/3/2018; 05222017@23 BUD: 5/17/2018; 06072017@28 BUD: 6/2/2018; 06122017@42 BUD: 6/7/2018; 06192017@24 BUD: 6/14/2018; 06292017@25 BUD: 6/24/2018; 07112017@33 BUD: 7/6/2018; 07172017@35 BUD: 7/12/2018; 07282017@26 BUD: 7/23/2018; 08012017@25 BUD: 7/27/2018; 08112017@35 BUD: 8/9/2018; 08142017@30 BUD: 8/9/2018; 08172017@31 BUD: 8/12/2018; 09202017@21 BUD: 9/15/2018; 09142017@27 BUD: 9/9/2018; 10022017@38 BUD: 3/31/2018; 10102017@37 BUD: 4/8/2018; 10172017@26 BUD: 4/15/2018; 10202017@22 BUD: 4/18/2018; 10302017@29 BUD: 4/28/2018
Distribution pattern Nationwide in the USA, Bermuda, and New Zealand
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[7264]
FDA event record
· Exact recall-number query on openFDA
drug · product 4 of 47
Arginine 150 mg/ Lysine HCl 50 mg/ Glutamine 200 mg/g Topical Cream packaged in jars, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd Boca Raton, FL 33487.
D-0164-2018
Recall number D-0164-2018
Initiated November 16, 2017
Classification Class II
Status Terminated
Quantity 490 jars
App-derived interpretation
Labeling or packaging
reason.labeling_packaging · v1.0.0
Labeling: Incorrect or Missing
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.
Code information Lot: 05242017@54 BUD: 11/20/2017
Distribution pattern Nationwide in the USA, Bermuda, and New Zealand
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[9656]
FDA event record
· Exact recall-number query on openFDA
drug · product 5 of 47
Benzocaine 20%, Lidocaine 6%, Tetracaine 4% Cream packaged in jars, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
D-0165-2018
Recall number D-0165-2018
Initiated November 16, 2017
Classification Class II
Status Terminated
Quantity 4,530 jars
App-derived interpretation
Labeling or packaging
reason.labeling_packaging · v1.0.0
Labeling: Incorrect or Missing
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.
Code information Lots: 06072017@22 BUD: 12/4/2017; 06222017@30 BUD: 12/19/2017; 08032017@31 BUD: 1/30/2018; 09212017@21 BUD: 3/20/2018; 10232017@20 BUD: 11/22/2017
Distribution pattern Nationwide in the USA, Bermuda, and New Zealand
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[7599]
FDA event record
· Exact recall-number query on openFDA
drug · product 6 of 47
Benzocaine 20%, Lidocaine 8%, Tetracaine 4% Topical Cream packaged in jars, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
D-0166-2018
Recall number D-0166-2018
Initiated November 16, 2017
Classification Class II
Status Terminated
Quantity 1,380 jars
App-derived interpretation
Labeling or packaging
reason.labeling_packaging · v1.0.0
Labeling: Incorrect or Missing
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.
Code information Lots: 07142017@31 BUD: 1/10/2018; 09202017@22 BUD: 3/19/2018; 10042017@25 BUD: 4/2/2018
Distribution pattern Nationwide in the USA, Bermuda, and New Zealand
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[9667]
FDA event record
· Exact recall-number query on openFDA
drug · product 7 of 47
Benzo/Lido/Tetracaine 20%-8%-8% Topical Cream packaged in jars, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
D-0167-2018
Recall number D-0167-2018
Initiated November 16, 2017
Classification Class II
Status Terminated
Quantity 3,280 jars
App-derived interpretation
Labeling or packaging
reason.labeling_packaging · v1.0.0
Labeling: Incorrect or Missing
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.
Code information Lots: 06072017@38 BUD: 12/4/2017; 07062017@48 BUD: 1/2/2018; 08012017@23 BUD: 1/28/2018; 08212017@36 BUD: 2/17/2018; 09182017@26 BUD: 3/17/2018
Distribution pattern Nationwide in the USA, Bermuda, and New Zealand
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[9452]
FDA event record
· Exact recall-number query on openFDA
drug · product 8 of 47
Bi-Est (Estriol/Estradiol) (80/20) + Progesterone 7.5 mg/200 mg Cream packaged in jars, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd Boca Raton, FL 33487.
D-0168-2018
Recall number D-0168-2018
Initiated November 16, 2017
Classification Class II
Status Terminated
Quantity 300 jars
App-derived interpretation
Labeling or packaging
reason.labeling_packaging · v1.0.0
Labeling: Incorrect or Missing
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.
Code information Lot: 08172017@39 BUD: 12/15/2017
Distribution pattern Nationwide in the USA, Bermuda, and New Zealand
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[9375]
FDA event record
· Exact recall-number query on openFDA
drug · product 9 of 47
Chloramphenicol 50 mg/ Sulfamethoxazole 50 mg/ Amphotericin-B 5 mg capsules, For OTIC Use Only, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
D-0169-2018
Recall number D-0169-2018
Initiated November 16, 2017
Classification Class II
Status Terminated
Quantity 90 capsules
App-derived interpretation
Labeling or packaging
reason.labeling_packaging · v1.0.0
Labeling: Incorrect or Missing
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.
Code information Lot: 08212017@24 BUD: 2/17/2018
Distribution pattern Nationwide in the USA, Bermuda, and New Zealand
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[9373]
FDA event record
· Exact recall-number query on openFDA
drug · product 10 of 47
Chloramphenicol 500 mg Amphotericin 50 mg Otic Powder packaged in jars, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
D-0170-2018
Recall number D-0170-2018
Initiated November 16, 2017
Classification Class II
Status Terminated
Quantity 20 jars
App-derived interpretation
Labeling or packaging
reason.labeling_packaging · v1.0.0
Labeling: Incorrect or Missing
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.
Code information Lot: 08162017@32 BUD: 2/12/2018
Distribution pattern Nationwide in the USA, Bermuda, and New Zealand
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[9580]
FDA event record
· Exact recall-number query on openFDA
drug · product 11 of 47
Chloramphenicol 500 mg Sulfamethoxazole 500 mg Amphotericin 50 mg Otic Powder packaged in jars, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
D-0171-2018
Recall number D-0171-2018
Initiated November 16, 2017
Classification Class II
Status Terminated
Quantity 100 jars
App-derived interpretation
Labeling or packaging
reason.labeling_packaging · v1.0.0
Labeling: Incorrect or Missing
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.
Code information Lots: 07282017@24 BUD: 1/24/2018; 08162017@33 BUD: 2/12/2018
Distribution pattern Nationwide in the USA, Bermuda, and New Zealand
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[7347]
FDA event record
· Exact recall-number query on openFDA
drug · product 12 of 47
Estriol 0.1% (1 mg/gm) Cream packaged in jars, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
D-0172-2018
Recall number D-0172-2018
Initiated November 16, 2017
Classification Class II
Status Terminated
Quantity 300 jars
App-derived interpretation
Labeling or packaging
reason.labeling_packaging · v1.0.0
Labeling: Incorrect or Missing
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.
Code information Lot: 07182017@45 BUD: 1/14/2018
Distribution pattern Nationwide in the USA, Bermuda, and New Zealand
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[7711]
FDA event record
· Exact recall-number query on openFDA
drug · product 13 of 47
Human Chorionic Gonadotropin 500 iu Orally Disintegrating Tablets (ODT), Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
D-0173-2018
Recall number D-0173-2018
Initiated November 16, 2017
Classification Class II
Status Terminated
Quantity 2,239 tablets
App-derived interpretation
Labeling or packaging
reason.labeling_packaging · v1.0.0
Labeling: Incorrect or Missing
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.
Code information Lot: 06132017@22 BUD: 12/10/2017
Distribution pattern Nationwide in the USA, Bermuda, and New Zealand
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[9664]
FDA event record
· Exact recall-number query on openFDA
drug · product 14 of 47
Human Chorionic Gonadotropin 2,500 Units, Vial-Lyophilized, For SC Use, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
D-0174-2018
Recall number D-0174-2018
Initiated November 16, 2017
Classification Class II
Status Terminated
Quantity 1,203 vials
App-derived interpretation
Labeling or packaging
reason.labeling_packaging · v1.0.0
Labeling: Incorrect or Missing
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.
Code information Lots: 06212017@19 BUD: 12/18/2017; 10052017@1 BUD: 4/3/2018
Distribution pattern Nationwide in the USA, Bermuda, and New Zealand
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[9555]
FDA event record
· Exact recall-number query on openFDA
drug · product 15 of 47
Human Chorionic Gonadotropin 5,000 iu/ Vial Lyophilized, For SC Use, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
D-0175-2018
Recall number D-0175-2018
Initiated November 16, 2017
Classification Class II
Status Terminated
Quantity 6,414 vials
App-derived interpretation
Labeling or packaging
reason.labeling_packaging · v1.0.0
Labeling: Incorrect or Missing
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.
Code information Lots: 06132017@2 BUD: 12/10/2017; 07262017@17 BUD: 1/22/2018; 10032017@1 BUD: 4/1/2018
Distribution pattern Nationwide in the USA, Bermuda, and New Zealand
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[9460]
FDA event record
· Exact recall-number query on openFDA
drug · product 16 of 47
Human Chorionic Gonadotropin 6,000 iu/Vial, For SC Use -Lyophilized, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
D-0176-2018
Recall number D-0176-2018
Initiated November 16, 2017
Classification Class II
Status Terminated
Quantity 2,239 vials
App-derived interpretation
Labeling or packaging
reason.labeling_packaging · v1.0.0
Labeling: Incorrect or Missing
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.
Code information Lot: 08302017@11 BUD: 2/26/2018
Distribution pattern Nationwide in the USA, Bermuda, and New Zealand
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[9650]
FDA event record
· Exact recall-number query on openFDA
drug · product 17 of 47
Human Chorionic Gonadotropin 11,000 iu/Vial Lyophilized For SC Use, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
D-0177-2018
Recall number D-0177-2018
Initiated November 16, 2017
Classification Class II
Status Terminated
Quantity 7,862 vials
App-derived interpretation
Labeling or packaging
reason.labeling_packaging · v1.0.0
Labeling: Incorrect or Missing
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.
Code information Lots: 06222017@10 BUD: 12/19/2017; 09272017@14 BUD: 3/26/2018; 05312017@5 BUD: 11/27/2017; 07192017@8 BUD: 1/15/2018
Distribution pattern Nationwide in the USA, Bermuda, and New Zealand
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[7353]
FDA event record
· Exact recall-number query on openFDA
drug · product 18 of 47
Human Chorionic Gonadotropin 20,000 iu/Vial, Lyophilized - For SC Use, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
D-0178-2018
Recall number D-0178-2018
Initiated November 16, 2017
Classification Class II
Status Terminated
Quantity 2,274 vials
App-derived interpretation
Labeling or packaging
reason.labeling_packaging · v1.0.0
Labeling: Incorrect or Missing
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.
Code information Lots: 06082017@33 BUD: 12/5/2017; 06152017@4 BUD: 12/12/2017; 07272017@4 BUD: 1/23/2018; 10042017@22 BUD: 4/2/2018; 09282017@3 BUD: 3/27/2018
Distribution pattern Nationwide in the USA, Bermuda, and New Zealand
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[7608]
FDA event record
· Exact recall-number query on openFDA
drug · product 19 of 47
Hydroquinone 8%/ Tretinoin 0.1% Topical Ointment packaged in jars, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
D-0179-2018
Recall number D-0179-2018
Initiated November 16, 2017
Classification Class II
Status Terminated
Quantity 30 jars
App-derived interpretation
Labeling or packaging
reason.labeling_packaging · v1.0.0
Labeling: Incorrect or Missing
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.
Code information Lot: 08222017@37 BUD: 11/20/2017
Distribution pattern Nationwide in the USA, Bermuda, and New Zealand
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[9761]
FDA event record
· Exact recall-number query on openFDA
drug · product 20 of 47
Hydroxocobalamin 0.5 mg/mL For Diluent Purpose Only 10 mL Vial, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
D-0180-2018
Recall number D-0180-2018
Initiated November 16, 2017
Classification Class II
Status Terminated
Quantity 1,009 vials
App-derived interpretation
Labeling or packaging
reason.labeling_packaging · v1.0.0
Labeling: Incorrect or Missing
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.
Code information Lot: 10102017@9 BUD: 2/7/2018
Distribution pattern Nationwide in the USA, Bermuda, and New Zealand
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[10010]
FDA event record
· Exact recall-number query on openFDA
drug · product 21 of 47
Hydroxocobalamin 1 mg/mL 30 mL Vial For IM Use, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
D-0181-2018
Recall number D-0181-2018
Initiated November 16, 2017
Classification Class II
Status Terminated
Quantity 596 vials
App-derived interpretation
Labeling or packaging
reason.labeling_packaging · v1.0.0
Labeling: Incorrect or Missing
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.
Code information Lot: 10162017@20 BUD: 2/13/2018
Distribution pattern Nationwide in the USA, Bermuda, and New Zealand
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[7267]
FDA event record
· Exact recall-number query on openFDA
drug · product 22 of 47
Iodochlorhydroxyquin 3%/ Boric Acid 10%/ Amphotericin 5% Otic Powder packaged in jars, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
D-0182-2018
Recall number D-0182-2018
Initiated November 16, 2017
Classification Class II
Status Terminated
Quantity 40 jars
App-derived interpretation
Labeling or packaging
reason.labeling_packaging · v1.0.0
Labeling: Incorrect or Missing
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.
Code information Lot: 07282017@23 BUD: 1/24/2018
Distribution pattern Nationwide in the USA, Bermuda, and New Zealand
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[9379]
FDA event record
· Exact recall-number query on openFDA
drug · product 23 of 47
Liothyronine SR (T3) 20 mcg Capsule, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd Boca Raton, FL 33487.
D-0183-2018
Recall number D-0183-2018
Initiated November 16, 2017
Classification Class II
Status Terminated
Quantity 970 capsules
App-derived interpretation
Labeling or packaging
reason.labeling_packaging · v1.0.0
Labeling: Incorrect or Missing
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.
Code information Lots: 05022017@24 BUD: 4/27/2018; 10122017@21 BUD: 4/10/2018; 11062017@38 BUD: 5/5/2018; 08252017@28 BUD: 8/20/2018
Distribution pattern Nationwide in the USA, Bermuda, and New Zealand
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[10005]
FDA event record
· Exact recall-number query on openFDA
drug · product 24 of 47
Methylene Blue (PF) 10 mg/mL (1%) Injectable Vial, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
D-0184-2018
Recall number D-0184-2018
Initiated November 16, 2017
Classification Class II
Status Terminated
Quantity 696 vials
App-derived interpretation
Labeling or packaging
reason.labeling_packaging · v1.0.0
Labeling: Incorrect or Missing
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.
Code information Lot: 09252017@7 BUD: 12/24/2017
Distribution pattern Nationwide in the USA, Bermuda, and New Zealand
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[9652]
FDA event record
· Exact recall-number query on openFDA
drug · product 25 of 47
Nicotinamide Adenine Dinucleotide 500 mg packaged in vials, Lyophilized-For IV Use, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
D-0185-2018
Recall number D-0185-2018
Initiated November 16, 2017
Classification Class II
Status Terminated
Quantity 2,535 vials
App-derived interpretation
Labeling or packaging
reason.labeling_packaging · v1.0.0
Labeling: Incorrect or Missing
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.
Code information Lot: 06062017@3 BUD: 12/3/2017
Distribution pattern Nationwide in the USA, Bermuda, and New Zealand
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[9567]
FDA event record
· Exact recall-number query on openFDA
drug · product 26 of 47
Oxytocin 30 Units in 0.9% Sodium Chloride Solution (PF) IV Bag, For IV Infusion Use, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
D-0186-2018
Recall number D-0186-2018
Initiated November 16, 2017
Classification Class II
Status Terminated
Quantity 963 bags
App-derived interpretation
Labeling or packaging
reason.labeling_packaging · v1.0.0
Labeling: Incorrect or Missing
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.
Code information Lots: 10112017@10 BUD: 1/9/2018; 10252017@9 BUD: 1/23/2018
Distribution pattern Nationwide in the USA, Bermuda, and New Zealand
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[10021]
FDA event record
· Exact recall-number query on openFDA
drug · product 27 of 47
PrednisoLONE 10 mg Tablet, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
D-0187-2018
Recall number D-0187-2018
Initiated November 16, 2017
Classification Class II
Status Terminated
Quantity 3,000 tablets
App-derived interpretation
Labeling or packaging
reason.labeling_packaging · v1.0.0
Labeling: Incorrect or Missing
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.
Code information Lot: 07172017@40 BUD: 1/13/2018
Distribution pattern Nationwide in the USA, Bermuda, and New Zealand
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[9457]
FDA event record
· Exact recall-number query on openFDA
drug · product 28 of 47
Progesterone 3% Topical Cream packaged in jars, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
D-0188-2018
Recall number D-0188-2018
Initiated November 16, 2017
Classification Class II
Status Terminated
Quantity 300 jars
App-derived interpretation
Labeling or packaging
reason.labeling_packaging · v1.0.0
Labeling: Incorrect or Missing
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.
Code information Lot: 09212017@22 BUD: 3/20/2018
Distribution pattern Nationwide in the USA, Bermuda, and New Zealand
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[10003]
FDA event record
· Exact recall-number query on openFDA
drug · product 29 of 47
QUADMIX #16, 5 mL Vial, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
D-0189-2018
Recall number D-0189-2018
Initiated November 16, 2017
Classification Class II
Status Terminated
Quantity 126 vials
App-derived interpretation
Labeling or packaging
reason.labeling_packaging · v1.0.0
Labeling: Incorrect or Missing
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.
Code information Lot: 05242017@25 BUD: 11/20/2017
Distribution pattern Nationwide in the USA, Bermuda, and New Zealand
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[9583]
FDA event record
· Exact recall-number query on openFDA
drug · product 30 of 47
QUADMIX #17, 5 mL Vial, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
D-0190-2018
Recall number D-0190-2018
Initiated November 16, 2017
Classification Class II
Status Terminated
Quantity 122 vials
App-derived interpretation
Labeling or packaging
reason.labeling_packaging · v1.0.0
Labeling: Incorrect or Missing
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.
Code information Lot: 05242017@27 BUD: 11/20/2017
Distribution pattern Nationwide in the USA, Bermuda, and New Zealand
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[10007]
FDA event record
· Exact recall-number query on openFDA
drug · product 31 of 47
QUADMIX #18, 5 mL Vial, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
D-0191-2018
Recall number D-0191-2018
Initiated November 16, 2017
Classification Class II
Status Terminated
Quantity 129 vials
App-derived interpretation
Labeling or packaging
reason.labeling_packaging · v1.0.0
Labeling: Incorrect or Missing
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.
Code information Lot: 05242017@29 BUD: 11/20/2017
Distribution pattern Nationwide in the USA, Bermuda, and New Zealand
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[7340]
FDA event record
· Exact recall-number query on openFDA
drug · product 32 of 47
Savinase 100 mcg/mL Topical Solution, 1 mL in a 3 mL Droptainer, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
D-0192-2018
Recall number D-0192-2018
Initiated November 16, 2017
Classification Class II
Status Terminated
Quantity 30 droptainers
App-derived interpretation
Labeling or packaging
reason.labeling_packaging · v1.0.0
Labeling: Incorrect or Missing
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.
Code information Lot: 06262017@31 BUD: 6/26/2018
Distribution pattern Nationwide in the USA, Bermuda, and New Zealand
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[9551]
FDA event record
· Exact recall-number query on openFDA
drug · product 33 of 47
Sermorelin 500 mcg Orally Disintegrating Tablets (ODT), Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
D-0193-2018
Recall number D-0193-2018
Initiated November 16, 2017
Classification Class II
Status Terminated
Quantity 3,000 tablets
App-derived interpretation
Labeling or packaging
reason.labeling_packaging · v1.0.0
Labeling: Incorrect or Missing
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.
Code information Lot: 07112017@32 BUD: 1/7/2018
Distribution pattern Nationwide in the USA, Bermuda, and New Zealand
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[9462]
FDA event record
· Exact recall-number query on openFDA
drug · product 34 of 47
Sermorelin, 3 mg/ GHRP6, 1.8 mg/ GHRP2, 1.8 mg/mL in 3 mL Cartridge, For SC Use, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
D-0194-2018
Recall number D-0194-2018
Initiated November 16, 2017
Classification Class II
Status Terminated
Quantity 80 cartridges
App-derived interpretation
Labeling or packaging
reason.labeling_packaging · v1.0.0
Labeling: Incorrect or Missing
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.
Code information Lot: 10122017@8 BUD: 2/9/2018
Distribution pattern Nationwide in the USA, Bermuda, and New Zealand
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[7239]
FDA event record
· Exact recall-number query on openFDA
drug · product 35 of 47
Sermorelin, 3 mg/ GHRP6, 3 mg/GHRP2, 3 mg, Vial - Lyophilized, For SC Use, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
D-0195-2018
Recall number D-0195-2018
Initiated November 16, 2017
Classification Class II
Status Terminated
Quantity 597 vials
App-derived interpretation
Labeling or packaging
reason.labeling_packaging · v1.0.0
Labeling: Incorrect or Missing
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.
Code information Lots: 06162017@12 BUD: 12/13/2017; 08042017@1 BUD: 1/31/2018
Distribution pattern Nationwide in the USA, Bermuda, and New Zealand
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[9771]
FDA event record
· Exact recall-number query on openFDA
drug · product 36 of 47
Sermorelin Acetate 3 mg/ GHRP6 3 mg, Lyophilized Vial, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
D-0196-2018
Recall number D-0196-2018
Initiated November 16, 2017
Classification Class II
Status Terminated
Quantity 157 vials
App-derived interpretation
Labeling or packaging
reason.labeling_packaging · v1.0.0
Labeling: Incorrect or Missing
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.
Code information Lot: 06272017@4 BUD: 12/24/2017
Distribution pattern Nationwide in the USA, Bermuda, and New Zealand
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[9387]
FDA event record
· Exact recall-number query on openFDA
drug · product 37 of 47
Sincalide 5 mcg Lyophilized Vials, For IV Use, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
D-0197-2018
Recall number D-0197-2018
Initiated November 16, 2017
Classification Class II
Status Terminated
Quantity 898 vials
App-derived interpretation
Labeling or packaging
reason.labeling_packaging · v1.0.0
Labeling: Incorrect or Missing
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.
Code information Lot: 07052017@2 BUD: 1/1/2018
Distribution pattern Nationwide in the USA, Bermuda, and New Zealand
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[7351]
FDA event record
· Exact recall-number query on openFDA
drug · product 38 of 47
Trimix #22F (Prostaglandin E1 25 mcg/ Papaverine HCl 30 mg/ Phentolamine Mesylate 2 mg/mL), For Intracavernous Use, 5 mL Vial, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
D-0198-2018
Recall number D-0198-2018
Initiated November 16, 2017
Classification Class II
Status Terminated
Quantity 235 vials
App-derived interpretation
Labeling or packaging
reason.labeling_packaging · v1.0.0
Labeling: Incorrect or Missing
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.
Code information Lot: 05262017@21 BUD: 11/22/2017; 07132017@2 BUD: 1/9/2018
Distribution pattern Nationwide in the USA, Bermuda, and New Zealand
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[7603]
FDA event record
· Exact recall-number query on openFDA
drug · product 39 of 47
Trimix #23F (Prostaglandin E1 6 mcg/ Papaverine HCl 17.8 mg/ Phentolamine Mesylate 0.6 mg/mL), For Intracavernous Use, 5 mL Vial, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
D-0199-2018
Recall number D-0199-2018
Initiated November 16, 2017
Classification Class II
Status Terminated
Quantity 94 vials
App-derived interpretation
Labeling or packaging
reason.labeling_packaging · v1.0.0
Labeling: Incorrect or Missing
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.
Code information Lot: 06142017@6 BUD: 12/11/2017
Distribution pattern Nationwide in the USA, Bermuda, and New Zealand
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[10024]
FDA event record
· Exact recall-number query on openFDA
drug · product 40 of 47
T-105 (Prostaglandin E1, 10 mcg/ Papaverine 30 mg/ Phentolamine 1 mg/mL), For Intracavernouse Use, 5 mL Vial, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
D-0200-2018
Recall number D-0200-2018
Initiated November 16, 2017
Classification Class II
Status Terminated
Quantity 173 vials
App-derived interpretation
Labeling or packaging
reason.labeling_packaging · v1.0.0
Labeling: Incorrect or Missing
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.
Code information Lot: 07122017@2 BUD: 1/8/2018
Distribution pattern Nationwide in the USA, Bermuda, and New Zealand
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[9466]
FDA event record
· Exact recall-number query on openFDA
drug · product 41 of 47
Cyclopentolate HCl/ Phenylephrine HCl/ Tropicamide/ Ketorolac 1%/ 2.5%/ 1%/ 0.5% Ophthalmic Solution, 3 mL Multi Dose Droptainer, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
D-0201-2018
Recall number D-0201-2018
Initiated November 16, 2017
Classification Class II
Status Terminated
Quantity 297 droptainers
App-derived interpretation
Labeling or packaging
reason.labeling_packaging · v1.0.0
Labeling: Incorrect or Missing
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.
Code information Lot: 09192017@20 BUD: 12/18/2017
Distribution pattern Nationwide in the USA, Bermuda, and New Zealand
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[7602]
FDA event record
· Exact recall-number query on openFDA
drug · product 42 of 47
Cyclopentolate HCl/ Phenylephrine HCl/ Tropicamide/ Ketorolac 1%/ 10%/ 1%/ 0.5% Ophthalmic Soln, 5 mL Multi Dose Droptainer, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
D-0202-2018
Recall number D-0202-2018
Initiated November 16, 2017
Classification Class II
Status Terminated
Quantity 81 droptainers
App-derived interpretation
Labeling or packaging
reason.labeling_packaging · v1.0.0
Labeling: Incorrect or Missing
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.
Code information Lot: 10042017@34 BUD: 1/2/2018
Distribution pattern Nationwide in the USA, Bermuda, and New Zealand
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[10019]
FDA event record
· Exact recall-number query on openFDA
drug · product 43 of 47
Vitamin 9 Lyophilized Vial, For IM Use, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
D-0203-2018
Recall number D-0203-2018
Initiated November 16, 2017
Classification Class II
Status Terminated
Quantity 479 vials
App-derived interpretation
Labeling or packaging
reason.labeling_packaging · v1.0.0
Labeling: Incorrect or Missing
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.
Code information Lot: 07102017@4 BUD: 1/6/2018
Distribution pattern Nationwide in the USA, Bermuda, and New Zealand
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[9570]
FDA event record
· Exact recall-number query on openFDA
drug · product 44 of 47
Vitamin 9 A/B Lyophilized Vial, For IM Use, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
D-0204-2018
Recall number D-0204-2018
Initiated November 16, 2017
Classification Class II
Status Terminated
Quantity 3612 vials
App-derived interpretation
Labeling or packaging
reason.labeling_packaging · v1.0.0
Labeling: Incorrect or Missing
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.
Code information Lots: 06092017@2 BUD: 12/6/2017; 07212017@16 BUD: 1/17/2018; 07312017@26 BUD: 1/27/2018; 08182017@5 BUD: 2/14/2018; 09222017@2 BUD: 3/21/2018; 09292017@2 BUD: 3/28/2018; 10062017@2 BUD: 4/4/2018
Distribution pattern Nationwide in the USA, Bermuda, and New Zealand
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[9453]
FDA event record
· Exact recall-number query on openFDA
drug · product 45 of 47
Vitamin 10 B Lyophilized Vial, For IM Use, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
D-0205-2018
Recall number D-0205-2018
Initiated November 16, 2017
Classification Class II
Status Terminated
Quantity 5786 vials
App-derived interpretation
Labeling or packaging
reason.labeling_packaging · v1.0.0
Labeling: Incorrect or Missing
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.
Code information Lots; 05232017@13 BUD: 11/19/2017; 05262017@2 BUD: 11/22/2017; 06022017@1 BUD: 11/29/2017; 06092017@1 BUD: 12/6/2017; 06162017@10 BUD: 12/13/2017; 08142017@10 BUD: 2/10/2018; 08252017@1 BUD: 2/21/2018; 09222017@1 BUD: 3/21/2018; 09292017@1 BUD: 3/28/2018; 10062017@1 BUD: 4/4/2018; 10132017@2 BUD: 4/11/2018
Distribution pattern Nationwide in the USA, Bermuda, and New Zealand
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[9385]
FDA event record
· Exact recall-number query on openFDA
drug · product 46 of 47
7-Ketodehydroepiandrosterone (7-Keto DHEA) 100 mg Capsule, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
D-0206-2018
Recall number D-0206-2018
Initiated November 16, 2017
Classification Class II
Status Terminated
Quantity 90 capsules
App-derived interpretation
Labeling or packaging
reason.labeling_packaging · v1.0.0
Labeling: Incorrect or Missing
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.
Code information Lot: 08012017@35 BUD: 1/28/2018
Distribution pattern Nationwide in the USA, Bermuda, and New Zealand
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[9468]
FDA event record
· Exact recall-number query on openFDA
drug · product 47 of 47
7-Keto DHEA 25mg Capsule, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
D-0207-2018
Recall number D-0207-2018
Initiated November 16, 2017
Classification Class II
Status Terminated
Quantity 90 capsules
App-derived interpretation
Labeling or packaging
reason.labeling_packaging · v1.0.0
Labeling: Incorrect or Missing
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.
Code information Lot: 06082017@36 BUD: 12/5/2017
Distribution pattern Nationwide in the USA, Bermuda, and New Zealand
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[7715]
FDA event record
· Exact recall-number query on openFDA
