Multi-event March 2014 FDA Recall Drug by John W Hollis Inc

This Multi-event Class II drug recall was voluntarily initiated by John W Hollis Inc on March 17, 2014 for the product Drug. The FDA reported the reason for recall as labeling. The product was distributed in MO, TN, MS, WI and the recall is currently terminated.

Reported Recall Events

D-1257-2014 TERMINATED D-1260-2014 TERMINATED D-1258-2014 TERMINATED D-1259-2014 TERMINATED

Recall Number: D-1257-2014

Reason for Recall
Labeling: Incorrect Expiration Date; Expiration date is earlier than listed on vial.
Initiated
03-17-2014
Reported
05-07-2014
Quantity
7 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
67812
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
John W Hollis Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
MO, TN, MS, WI
Termination Date About Termination Date
Date that FDA officially terminated the recall.
05-01-2014
Product Description About Product Description
Full technical description of the product.
Phosphatidylcholine Solution for Injection, 50 mg/ mL, 50 mL Vial, Rx Only, Not for Resale. John Hollis Pharmacy, 110 20th Avenue N, Nashville, TN 37203.

Batch or Lot Expiration Information

Lot# : 41652, Expiry: 8/2/14
Lot# : 41668, Expiry: 7/13/14

Recall Number: D-1260-2014

Reason for Recall
Presence of Particulate Matter
Initiated
03-17-2014
Reported
05-07-2014
Quantity
3 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
67812
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
John W Hollis Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
MO, TN, MS, WI
Termination Date About Termination Date
Date that FDA officially terminated the recall.
05-01-2014
Product Description About Product Description
Full technical description of the product.
Polidocanol 3% Solution, 50 mL Vial, Rx Only, Not for Resale. John Hollis Pharmacy, 110 20th Avenue N, Nashville, TN 37203.

Batch or Lot Expiration Information

Lot# : 641:07, Expiry: 8/11/14

Recall Number: D-1258-2014

Reason for Recall
Labeling: Incorrect Expiration Date; Expiration date is earlier than listed on vial.
Initiated
03-17-2014
Reported
05-07-2014
Quantity
1 vial

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
67812
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
John W Hollis Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
MO, TN, MS, WI
Termination Date About Termination Date
Date that FDA officially terminated the recall.
05-01-2014
Product Description About Product Description
Full technical description of the product.
Papaverine 60 mg, Phentolamine 4 mg, and Atropine 0.3 mg Solution, 10 mL Vial, Rx Only. Not for Resale. John Hollis Pharmacy, 110 20th Avenue N, Nashville, TN 37203.

Batch or Lot Expiration Information

Lot# : 1905, Expiry: 4/30/14

Recall Number: D-1259-2014

Reason for Recall
Labeling: Incorrect Expiration Date; Expiration date is earlier than listed on vial.
Initiated
03-17-2014
Reported
05-07-2014
Quantity
2 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
67812
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
John W Hollis Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
MO, TN, MS, WI
Termination Date About Termination Date
Date that FDA officially terminated the recall.
05-01-2014
Product Description About Product Description
Full technical description of the product.
Polidocanol 1% Solution, 50 mL Vial, Rx Only, Not for Resale. John Hollis Pharmacy, 110 20th Avenue N, Nashville, TN 37203.

Batch or Lot Expiration Information

Lot# : 565:27, Expiry: 5/31/14