Multi-event February 2016 FDA Recall Drug by Hartley Medical Center Pharmacy, Incorporated
This Multi-event Class II drug recall was voluntarily initiated by Hartley Medical Center Pharmacy, Incorporated on February 4, 2016 for the product Drug. The FDA reported the reason for recall as lack of assurance of sterility. The product was distributed Nationwide and the recall is currently terminated.
Reported Recall Events
D-0744-2016 D-0746-2016 D-0748-2016 D-0749-2016 D-0763-2016 D-0743-2016 D-0754-2016 D-0740-2016 D-0741-2016 D-0758-2016 D-0760-2016 D-0764-2016 D-0761-2016 D-0738-2016 D-0759-2016 D-0739-2016 D-0751-2016 D-0737-2016 D-0742-2016 D-0750-2016 D-0757-2016 D-0752-2016 D-0753-2016 D-0747-2016 D-0765-2016 D-0745-2016 D-0755-2016 D-0736-2016 D-0762-2016 D-0756-2016
Recall Number: D-0744-2016
Lack of Assurance of Sterility
02-04-2016
03-16-2016
1 syringe
Recall Profile & Regulatory Data
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.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Hartley Medical Center Pharmacy, Incorporated
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide. No foreign distribution.
08-09-2016
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Morphine Sulfate 20 mg/ml/Bupivacaine HCL 11.3 mg/ml, vol. 40 ml syringe, Rx only, Hartley Med Ctr Pharmacy, Long Beach, CA
Batch or Lot Expiration Information
Lot# BUD: 5/3/2016
Recall Number: D-0746-2016
Lack of Assurance of Sterility
02-04-2016
03-16-2016
1 syringe
Recall Profile & Regulatory Data
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.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Hartley Medical Center Pharmacy, Incorporated
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide. No foreign distribution.
08-09-2016
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Hydromorphone HCL 10 mg/ml/Bupivacaine HCL 30 mg/ml, vol. 20 ml syringe, Rx only, Hartley Med Ctr Pharmacy, Long Beach, CA
Batch or Lot Expiration Information
Lot# BUD: 5/3/2016
Recall Number: D-0748-2016
Lack of Assurance of Sterility
02-04-2016
03-16-2016
1 syringe
Recall Profile & Regulatory Data
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.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Hartley Medical Center Pharmacy, Incorporated
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide. No foreign distribution.
08-09-2016
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Baclofen 2000 mcg/ml, vol. 20 ml syringe, Rx only, Hartley Med Ctr Pharmacy, Long Beach, CA
Batch or Lot Expiration Information
Lot# BUD: 5/3/2016
Recall Number: D-0749-2016
Lack of Assurance of Sterility
02-04-2016
03-16-2016
1 syringe
Recall Profile & Regulatory Data
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.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Hartley Medical Center Pharmacy, Incorporated
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide. No foreign distribution.
08-09-2016
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Hydromorphone HCL 20 mg/ml/Bupivacaine HCL 40 mg/ml, vol. 20 ml syringe Rx only, Hartley Med Ctr Pharmacy, Long Beach, CA
Batch or Lot Expiration Information
Lot# BUD: 5/3/2016
Recall Number: D-0763-2016
Lack of Assurance of Sterility
02-04-2016
03-16-2016
1 syringe
Recall Profile & Regulatory Data
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.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Hartley Medical Center Pharmacy, Incorporated
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide. No foreign distribution.
08-09-2016
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Morphine Sulfate 0.5 mg/ml, vol. 20 ml syringe, Rx only, Hartley Med Ctr Pharmacy, Long Beach, CA
Batch or Lot Expiration Information
Lot# BUD: 5/3/2016
Recall Number: D-0743-2016
Lack of Assurance of Sterility
02-04-2016
03-16-2016
2 syringes
Recall Profile & Regulatory Data
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.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Hartley Medical Center Pharmacy, Incorporated
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide. No foreign distribution.
08-09-2016
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Morphine Sulfate 0.6 mg/ml, vol. 200 ml syringe, Rx only, Hartley Med Ctr Pharmacy, Long Beach, CA
Batch or Lot Expiration Information
Lot# BUD: 5/3/2016
Recall Number: D-0754-2016
Lack of Assurance of Sterility
02-04-2016
03-16-2016
2 syringes
Recall Profile & Regulatory Data
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.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Hartley Medical Center Pharmacy, Incorporated
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide. No foreign distribution.
08-09-2016
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Morphine Sulfate 1.5 mg/ml, vol. 20 ml syringe, Rx only, Hartley Med Ctr Pharmacy, Long Beach, CA
Batch or Lot Expiration Information
Lot# BUD: 5/3/2016
Recall Number: D-0740-2016
Lack of Assurance of Sterility
02-04-2016
03-16-2016
1 syringe
Recall Profile & Regulatory Data
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.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Hartley Medical Center Pharmacy, Incorporated
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide. No foreign distribution.
08-09-2016
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Hydromorphone 12 mg/ml/Baclofen 450 mcg/ml, vol. 20 ml, syringe, Rx only, Hartley Med Ctr Pharmacy, Long Beach, CA
Batch or Lot Expiration Information
Lot# BUD: 5/3/2016
Recall Number: D-0741-2016
Lack of Assurance of Sterility
02-04-2016
03-16-2016
1 vial
Recall Profile & Regulatory Data
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.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Hartley Medical Center Pharmacy, Incorporated
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide. No foreign distribution.
08-09-2016
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Morphine Sulfate 9 mg/ml/Sufentanil Cit 180 mcg/ml/Bupivacaine HCL 33 mg/ml, vol. 20 ml vial, Rx only, Hartley Med Ctr Pharmacy, Long Beach, CA
Batch or Lot Expiration Information
Lot# BUD: 5/3/2016
Recall Number: D-0758-2016
Lack of Assurance of Sterility
02-04-2016
03-16-2016
1 syringe
Recall Profile & Regulatory Data
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.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Hartley Medical Center Pharmacy, Incorporated
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide. No foreign distribution.
08-09-2016
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Hydromorphone HCL 10 mg/ml/Bupivacaine HCL 4 mg/ml, vol. 20 ml syringe, Rx only, Hartley Med Ctr Pharmacy, Long Beach, CA
Batch or Lot Expiration Information
Lot# BUD: 5/3/2016
Recall Number: D-0760-2016
Lack of Assurance of Sterility
02-04-2016
03-16-2016
1 syringe
Recall Profile & Regulatory Data
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.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Hartley Medical Center Pharmacy, Incorporated
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide. No foreign distribution.
08-09-2016
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Hydromorphone HCL 7 mg/ml/Bupivacaine HCL 11.2 mg/ml, vol. 40 ml syringe, Rx only, Hartley Med Ctr Pharmacy, Long Beach, CA
Batch or Lot Expiration Information
Lot# BUD: 5/3/2016
Recall Number: D-0764-2016
Lack of Assurance of Sterility
02-04-2016
03-16-2016
1 syringe
Recall Profile & Regulatory Data
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.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Hartley Medical Center Pharmacy, Incorporated
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide. No foreign distribution.
08-09-2016
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Hydromorphone HCL 0.5 mg/ml, vol. 20 ml syringe, Rx only, Hartley Med Ctr Pharmacy, Long Beach, CA
Batch or Lot Expiration Information
Lot# BUD: 5/3/2016
Recall Number: D-0761-2016
Lack of Assurance of Sterility
02-04-2016
03-16-2016
1 syringe
Recall Profile & Regulatory Data
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.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Hartley Medical Center Pharmacy, Incorporated
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide. No foreign distribution.
08-09-2016
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Sufentanil Cit 200 mcg/ml/Clonidine HCL 1600 mcg/ml, vol. 42 ml syringe, Rx only, Hartley Med Ctr Pharmacy, Long Beach, CA
Batch or Lot Expiration Information
Lot# BUD: 5/3/2016
Recall Number: D-0738-2016
Lack of Assurance of Sterility
02-04-2016
03-16-2016
1 syringe
Recall Profile & Regulatory Data
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.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Hartley Medical Center Pharmacy, Incorporated
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide. No foreign distribution.
08-09-2016
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Hydromorphone HCL 10 mg/ml/Baclofen 460 mcg/ml/Bupivacaine HCL, vol. 40 ml syringe, Rx only, Hartley Med Ctr Pharmacy, Long Beach, CA
Batch or Lot Expiration Information
Lot# BUD: 5/3/2016
Recall Number: D-0759-2016
Lack of Assurance of Sterility
02-04-2016
03-16-2016
1 syringe
Recall Profile & Regulatory Data
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.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Hartley Medical Center Pharmacy, Incorporated
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide. No foreign distribution.
08-09-2016
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Morphine Sulfate 11 mg/ml, vol. 20 ml syringe, Rx only, Hartley Med Ctr Pharmacy, Long Beach, CA
Batch or Lot Expiration Information
Lot# BUD: 5/3/2016
Recall Number: D-0739-2016
Lack of Assurance of Sterility
02-04-2016
03-16-2016
1 syringe
Recall Profile & Regulatory Data
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.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Hartley Medical Center Pharmacy, Incorporated
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide. No foreign distribution.
08-09-2016
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Morphine Sulfate 0.5 mg/ml/Baclofen 1000 mcg/ml/, vol. 20 ml syringe, Rx only, Hartley Med Ctr Pharmacy, Long Beach, CA
Batch or Lot Expiration Information
Lot# BUD: 5/3/2016
Recall Number: D-0751-2016
Lack of Assurance of Sterility
02-04-2016
03-16-2016
1 syringe
Recall Profile & Regulatory Data
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.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Hartley Medical Center Pharmacy, Incorporated
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide. No foreign distribution.
08-09-2016
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Hydromorphone HCL 10 mg/ml/Fentanyl Citrate 0.15 mg/ml, vol. 40 ml syringe, Rx only, Hartley Med Ctr Pharmacy, Long Beach, CA
Batch or Lot Expiration Information
Lot# BUD: 5/3/2016
Recall Number: D-0737-2016
Lack of Assurance of Sterility
02-04-2016
03-16-2016
1 syringe
Recall Profile & Regulatory Data
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.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Hartley Medical Center Pharmacy, Incorporated
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide. No foreign distribution.
08-09-2016
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Baclofen 5000 mcg/ml, vol. 20 ml syringe, Rx only, Hartley Med Ctr Pharmacy, Long Beach, CA
Batch or Lot Expiration Information
Lot# BUD: 5/3/2016
Recall Number: D-0742-2016
Lack of Assurance of Sterility
02-04-2016
03-16-2016
1 syringe
Recall Profile & Regulatory Data
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.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Hartley Medical Center Pharmacy, Incorporated
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide. No foreign distribution.
08-09-2016
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Sufentanil Cit 1000 mcg/ml/Baclofen 300 mcg/ml, vol. 20 ml syringe, Rx only, Hartley Med Ctr Pharmacy, Long Beach, CA
Batch or Lot Expiration Information
Lot# BUD: 5/3/2016
Recall Number: D-0750-2016
Lack of Assurance of Sterility
02-04-2016
03-16-2016
1 syringe
Recall Profile & Regulatory Data
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.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Hartley Medical Center Pharmacy, Incorporated
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide. No foreign distribution.
08-09-2016
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Hydromorphone HCL 25 mg/ml, vol. 40 ml syringe, Rx only, Hartley Med Ctr Pharmacy, Long Beach, CA
Batch or Lot Expiration Information
Lot# BUD: 5/3/2016
Recall Number: D-0757-2016
Lack of Assurance of Sterility
02-04-2016
03-16-2016
1 syringe
Recall Profile & Regulatory Data
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.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Hartley Medical Center Pharmacy, Incorporated
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide. No foreign distribution.
08-09-2016
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Hydromorphone HCL 25 mg/ml/Bupivacaine HCL 4 mg/ml, vol. 40 ml syringe, Rx only, Hartley Med Ctr Pharmacy, Long Beach, CA
Batch or Lot Expiration Information
Lot# BUD: 5/3/2016
Recall Number: D-0752-2016
Lack of Assurance of Sterility
02-04-2016
03-16-2016
1 syringe
Recall Profile & Regulatory Data
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.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Hartley Medical Center Pharmacy, Incorporated
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide. No foreign distribution.
08-09-2016
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Hydromorphone HCL 10 mg/ml, vol. 40 ml syringe, Rx only, Hartley Med Ctr Pharmacy, Long Beach, CA
Batch or Lot Expiration Information
Lot# BUD: 5/3/2016
Recall Number: D-0753-2016
Lack of Assurance of Sterility
02-04-2016
03-16-2016
1 syringe
Recall Profile & Regulatory Data
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.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Hartley Medical Center Pharmacy, Incorporated
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide. No foreign distribution.
08-09-2016
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Hydromorphone HCL 2 mg/ml, vol. 20 ml syringe, Rx only, Hartley Med Ctr Pharmacy Long Beach, CA
Batch or Lot Expiration Information
Lot# BUD: 5/3/2016
Recall Number: D-0747-2016
Lack of Assurance of Sterility
02-04-2016
03-16-2016
1 syringe
Recall Profile & Regulatory Data
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.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Hartley Medical Center Pharmacy, Incorporated
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide. No foreign distribution.
08-09-2016
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Morphine Sulfate 10 mg/ml, vol. 20 ml syringe, Rx only, Hartley Med Ctr Pharmacy, Long Beach, CA
Batch or Lot Expiration Information
Lot# BUD: 5/3/2016
Recall Number: D-0765-2016
Lack of Assurance of Sterility
02-04-2016
03-16-2016
1 syringe
Recall Profile & Regulatory Data
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.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Hartley Medical Center Pharmacy, Incorporated
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide. No foreign distribution.
08-09-2016
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Sufentanil Cit 50 mcg/ml/Clonidine HCL 1 mcg/ml/Bupivacaine HCL 5 mg/ml, vol. 20 ml syringe, Rx only, Hartley Med Ctr Pharmacy, Long Beach, CA
Batch or Lot Expiration Information
Lot# BUD: 5/3/2016
Recall Number: D-0745-2016
Lack of Assurance of Sterility
02-04-2016
03-16-2016
1 syringe
Recall Profile & Regulatory Data
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.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Hartley Medical Center Pharmacy, Incorporated
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide. No foreign distribution.
08-09-2016
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Morphine Sulfate 50 mg/ml/Bupivacaine HCL 24 mg/ml, vol. 20 ml syringe, Rx only, Hartley Med Ctr Pharmacy, Long Beach, CA
Batch or Lot Expiration Information
Lot# BUD: 5/3/2016
Recall Number: D-0755-2016
Lack of Assurance of Sterility
02-04-2016
03-16-2016
1 syringe
Recall Profile & Regulatory Data
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.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Hartley Medical Center Pharmacy, Incorporated
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide. No foreign distribution.
08-09-2016
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Fentanyl Citrate 1.275 mg/ml/Baclofen 150 mcg/ml/Bupivacaine HCL 20 mg/ml/ Clonidine HCL 450 mcg/ml, vol. 40 ml syringe, Rx only, Hartley Med Ctr Pharmacy, Long Beach, CA
Batch or Lot Expiration Information
Lot# BUD: 5/3/2016
Recall Number: D-0736-2016
Lack of Assurance of Sterility
02-04-2016
03-16-2016
1 syringe
Recall Profile & Regulatory Data
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.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Hartley Medical Center Pharmacy, Incorporated
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide. No foreign distribution.
08-09-2016
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Morphine Sulfate 6 mg/ml/Bupivacaine HCL 32 mg/ml, vol. 22 ml syringe, Rx only, Hartley Med Ctr Pharmacy, Long Beach, CA
Batch or Lot Expiration Information
Lot# BUD: 5/3/2016
Recall Number: D-0762-2016
Lack of Assurance of Sterility
02-04-2016
03-16-2016
1 syringe
Recall Profile & Regulatory Data
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.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Hartley Medical Center Pharmacy, Incorporated
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide. No foreign distribution.
08-09-2016
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Morphine Sulfate 20 mg/ml, vol. 42 ml syringe, Rx only, Hartley Med Ctr Pharmacy, Long Beach, CA
Batch or Lot Expiration Information
Lot# BUD: 5/3/2016
Recall Number: D-0756-2016
Lack of Assurance of Sterility
02-04-2016
03-16-2016
2 syringes
Recall Profile & Regulatory Data
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.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Hartley Medical Center Pharmacy, Incorporated
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide. No foreign distribution.
08-09-2016
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Hydromorphone HCL 1 mg/ml, vol. 22 ml syringe, Rx only, Hartley Med Ctr Pharmacy, Long Beach, CA
Batch or Lot Expiration Information
Lot# BUD: 5/3/2016
