Exact FDA event identifier

Event 80633

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

Event summary

Timeline bucket: July 25, 2018
Product types: Drug
Classifications: Class II
Statuses: Terminated
Recalling firm wording: Ranier's Compounding Laboratory

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

15 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 15

Atropine 0.01% Opth Solution, 5 mL droptainer, Rx only, Ranier's Rx Laboratory, 1107 Lowry Avenue Suite A, Jeannette, PA 15644.

D-1080-2018

Recall number: D-1080-2018
Initiated: July 25, 2018
Classification: Class II
Status: Terminated
Recalling firm: Ranier's Compounding Laboratory
Quantity: 5 droptainers

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile.

Code information

All lots within expiry

Distribution pattern

Product was distributed within the state of Pennsylvania.

drug · product 2 of 15

DMSO 6.25% Opth Sol, 10 mL droptainer, Rx only, Ranier's Rx Laboratory, 1107 Lowry Avenue Suite A, Jeannette, PA 15644.

D-1081-2018

Recall number: D-1081-2018
Initiated: July 25, 2018
Classification: Class II
Status: Terminated
Recalling firm: Ranier's Compounding Laboratory
Quantity: 1 droptainer

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile.

Code information

All lots within expiry

Distribution pattern

Product was distributed within the state of Pennsylvania.

drug · product 3 of 15

Avastin 1.25 mg/0.05 mL prefilled syringe, Rx only, Ranier's Rx Laboratory, 1107 Lowry Avenue Suite A, Jeannette, PA 15644.

D-1082-2018

Recall number: D-1082-2018
Initiated: July 25, 2018
Classification: Class II
Status: Terminated
Recalling firm: Ranier's Compounding Laboratory
Quantity: 213 prefilled syringes

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile.

Code information

All lots within expiry

Distribution pattern

Product was distributed within the state of Pennsylvania.

drug · product 4 of 15

Triple P (Prostaglandin/Papaverine/Phentolamine) Injection, 0.008/22.5/0.83 mg/mL, packaged in a) 5 mL and b) 10 mL vials, Rx only, Ranier's Rx Laboratory, 1107 Lowry Avenue Suite A, Jeannette, PA 15644.

D-1083-2018

Recall number: D-1083-2018
Initiated: July 25, 2018
Classification: Class II
Status: Terminated
Recalling firm: Ranier's Compounding Laboratory
Quantity: a) 1 vial; b) 1 vial

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile.

Code information

All lots within expiry

Distribution pattern

Product was distributed within the state of Pennsylvania.

drug · product 5 of 15

PR/PA/PH (Prostaglandin/Papaverine/Phentolamine) Injection, 10mcg/30/1mg/mL, 10 mL vial, Rx only, Ranier's Rx Laboratory, 1107 Lowry Avenue Suite A, Jeannette, PA 15644.

D-1084-2018

Recall number: D-1084-2018
Initiated: July 25, 2018
Classification: Class II
Status: Terminated
Recalling firm: Ranier's Compounding Laboratory
Quantity: 1 vial

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile.

Code information

All lots within expiry

Distribution pattern

Product was distributed within the state of Pennsylvania.

drug · product 6 of 15

Morphine Sulf inhalation, 5mg/3cc, 3cc per vial, Rx only, Ranier's Rx Laboratory, 1107 Lowry Avenue Suite A, Jeannette, PA 15644.

D-1085-2018

Recall number: D-1085-2018
Initiated: July 25, 2018
Classification: Class II
Status: Terminated
Recalling firm: Ranier's Compounding Laboratory
Quantity: 60 vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile.

Code information

All lots within expiry

Distribution pattern

Product was distributed within the state of Pennsylvania.

drug · product 7 of 15

Dehydrated Alcohol Solution, packaged in a) 1 mL and b) 3 mL vials, Rx only, Ranier's Rx Laboratory, 1107 Lowry Avenue Suite A, Jeannette, PA 15644.

D-1086-2018

Recall number: D-1086-2018
Initiated: July 25, 2018
Classification: Class II
Status: Terminated
Recalling firm: Ranier's Compounding Laboratory
Quantity: a) 2 vials; b) 1 vial

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile.

Code information

All lots within expiry

Distribution pattern

Product was distributed within the state of Pennsylvania.

drug · product 8 of 15

Vitamin D3 Injection, 50,000 IU/mL, 4 mL vial, Rx only, Ranier's Rx Laboratory, 1107 Lowry Avenue Suite A, Jeannette, PA 15644.

D-1087-2018

Recall number: D-1087-2018
Initiated: July 25, 2018
Classification: Class II
Status: Terminated
Recalling firm: Ranier's Compounding Laboratory
Quantity: 2 vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile.

Code information

All lots within expiry

Distribution pattern

Product was distributed within the state of Pennsylvania.

drug · product 9 of 15

Medroxprogesterone 1% Ophthalmic Solution, 10 mL droptainer, Rx only, Ranier's Rx Laboratory, 1107 Lowry Avenue Suite A, Jeannette, PA 15644.

D-1088-2018

Recall number: D-1088-2018
Initiated: July 25, 2018
Classification: Class II
Status: Terminated
Recalling firm: Ranier's Compounding Laboratory
Quantity: 1 droptainer

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile.

Code information

All lots within expiry

Distribution pattern

Product was distributed within the state of Pennsylvania.

drug · product 10 of 15

Acetylcysteine 10% Oph Solution, 10 mL droptainer, Rx only, Ranier's Rx Laboratory, 1107 Lowry Avenue Suite A, Jeannette, PA 15644.

D-1089-2018

Recall number: D-1089-2018
Initiated: July 25, 2018
Classification: Class II
Status: Terminated
Recalling firm: Ranier's Compounding Laboratory
Quantity: 1 droptainer

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile.

Code information

All lots with expiry

Distribution pattern

Product was distributed within the state of Pennsylvania.

drug · product 11 of 15

P/P/P (Prostaglandin/Papaverine/Phentolamine) Injection, 0.02/30/2 mg/mL, 5 mL vial, Rx only, Ranier's Rx Laboratory, 1107 Lowry Avenue Suite A, Jeannette, PA 15644.

D-1090-2018

Recall number: D-1090-2018
Initiated: July 25, 2018
Classification: Class II
Status: Terminated
Recalling firm: Ranier's Compounding Laboratory
Quantity: 2 vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile.

Code information

All lots within expiry

Distribution pattern

Product was distributed within the state of Pennsylvania.

drug · product 12 of 15

PRASH 12.2mcg/1.22m/19.29 (Prostaglandin/Phentolamine/Papaverine) Injection, 10 mL vial, Rx only, Ranier's Rx Laboratory, 1107 Lowry Avenue Suite A, Jeannette, PA 15644.

D-1091-2018

Recall number: D-1091-2018
Initiated: July 25, 2018
Classification: Class II
Status: Terminated
Recalling firm: Ranier's Compounding Laboratory
Quantity: 1 vial

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile.

Code information

All lots within expiry

Distribution pattern

Product was distributed within the state of Pennsylvania.

drug · product 13 of 15

PRO/PA/PH/AT 18mcg/1.8mg/ (Prostaglandin//Papaverine/Phentolamine/Atropine) Injection, 18mcg/1.8 mg/0.2 mg/0.02 mg/mL, 10 mL vial, Rx only, Ranier's Rx Laboratory, 1107 Lowry Avenue Suite A, Jeannette, PA 15644.

D-1092-2018

Recall number: D-1092-2018
Initiated: July 25, 2018
Classification: Class II
Status: Terminated
Recalling firm: Ranier's Compounding Laboratory
Quantity: 1 vial

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile.

Code information

All lots within expiry

Distribution pattern

Product was distributed within the state of Pennsylvania.

drug · product 14 of 15

P/P/P 0.02/40/2mg/mL(Prostaglandin//Papaverine/Phentolamine) Injection, 0.02/40/2 mg/mL, 1 mL vial, Rx only, Ranier's Rx Laboratory, 1107 Lowry Avenue Suite A, Jeannette, PA 15644.

D-1093-2018

Recall number: D-1093-2018
Initiated: July 25, 2018
Classification: Class II
Status: Terminated
Recalling firm: Ranier's Compounding Laboratory
Quantity: 1 vial

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile.

Code information

All lots within expiry

Distribution pattern

Product was distributed within the state of Pennsylvania.

drug · product 15 of 15

Papav 300/Phent 5mg/10mL (Papaverine/Phentolamine) Injection,300 mg/5 mg/10 mL, 10 mL vial, Rx only, Ranier's Rx Laboratory, 1107 Lowry Avenue Suite A, Jeannette, PA 15644.

D-1094-2018

Recall number: D-1094-2018
Initiated: July 25, 2018
Classification: Class II
Status: Terminated
Recalling firm: Ranier's Compounding Laboratory
Quantity: 2 vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile.

Code information

All lots within expiry

Distribution pattern

Product was distributed within the state of Pennsylvania.