Multi-event September 2015 FDA Recall Drug by Us Compounding Inc

This Multi-event Class II drug recall was voluntarily initiated by Us Compounding Inc on September 12, 2015 for the product Drug. The FDA reported the reason for recall as lack of assurance of sterility; the firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.. The product was distributed Nationwide and the recall is currently terminated.

Reported Recall Events

D-0254-2016 TERMINATED D-0273-2016 TERMINATED D-0237-2016 TERMINATED D-0286-2016 TERMINATED D-0245-2016 TERMINATED D-0276-2016 TERMINATED D-0262-2016 TERMINATED D-0283-2016 TERMINATED D-0285-2016 TERMINATED D-0253-2016 TERMINATED D-0293-2016 TERMINATED D-0243-2016 TERMINATED D-0270-2016 TERMINATED D-0249-2016 TERMINATED D-0277-2016 TERMINATED D-0269-2016 TERMINATED D-0260-2016 TERMINATED D-0247-2016 TERMINATED D-0257-2016 TERMINATED D-0280-2016 TERMINATED D-0274-2016 TERMINATED D-0256-2016 TERMINATED D-0248-2016 TERMINATED D-0289-2016 TERMINATED D-0244-2016 TERMINATED D-0240-2016 TERMINATED D-0278-2016 TERMINATED D-0287-2016 TERMINATED D-0255-2016 TERMINATED D-0275-2016 TERMINATED D-0281-2016 TERMINATED D-0284-2016 TERMINATED D-0238-2016 TERMINATED D-0288-2016 TERMINATED D-0251-2016 TERMINATED D-0236-2016 TERMINATED D-0264-2016 TERMINATED D-0266-2016 TERMINATED D-0263-2016 TERMINATED D-0242-2016 TERMINATED D-0261-2016 TERMINATED D-0290-2016 TERMINATED D-0272-2016 TERMINATED D-0252-2016 TERMINATED D-0291-2016 TERMINATED D-0268-2016 TERMINATED D-0265-2016 TERMINATED D-0271-2016 TERMINATED D-0279-2016 TERMINATED D-0282-2016 TERMINATED D-0250-2016 TERMINATED D-0239-2016 TERMINATED D-0292-2016 TERMINATED D-0259-2016 TERMINATED D-0258-2016 TERMINATED D-0294-2016 TERMINATED D-0246-2016 TERMINATED D-0241-2016 TERMINATED D-0267-2016 TERMINATED

Recall Number: D-0254-2016

Reason for Recall
Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.
Initiated
09-12-2015
Reported
11-25-2015
Quantity
7,852 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
72179
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.
US Compounding 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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-30-2017
Product Description About Product Description
Full technical description of the product.
HCG/B12 (5,000 units, 0.6 mg) 5 mL, Multi-Dose Vial, For IM or SC Injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3083-99

Batch or Lot Expiration Information

Lot# Lot Numbers: 20150806@22 BUD: 12/5/2015; 20150106@12 BUD: 11/28/2015; 20150106@20 BUD: 11/28/2015; 20150604@2 BUD: 10/3/2015; 20150604@2 BUD: 10/3/2015; 20150607@9 BUD: 1/2/2016; 20150806@22 BUD: 12/5/2015; 20151304@13 BUD: 10/10/2015; 20151506@22 BUD: 12/12/2015; 20152007@4 BUD: 1/16/2016; 20152206@20 BUD: 12/19/2015; 20152303@11 BUD: 9/19/2015; 20152303@2 BUD: 9/19/2015; 20152704@2 BUD: 10/24/2015; 20152707@3 BUD: 1/23/2016; 20152707@9 BUD: 1/23/2016; 20152303@11 BUD: 9/19/2015

Recall Number: D-0273-2016

Reason for Recall
Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.
Initiated
09-12-2015
Reported
11-25-2015
Quantity
542 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
72179
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.
US Compounding 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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-30-2017
Product Description About Product Description
Full technical description of the product.
Phenylephrine 1.5%/ Lidocaine 1%, 1 mL Single Use Vial, For Intracameral Injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3155-01

Batch or Lot Expiration Information

Lot# Lot Code: 20151506@31 BUD: 9/13/2015

Recall Number: D-0237-2016

Reason for Recall
Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.
Initiated
09-12-2015
Reported
11-25-2015
Quantity
82 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
72179
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.
US Compounding 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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-30-2017
Product Description About Product Description
Full technical description of the product.
Alprostadil (PGE-1), 5 mL (40 mcg/mL) in 10 mL Multi-Dose Vial, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC: 62295-3253-05.

Batch or Lot Expiration Information

Lot# Lot Numbers: 20150408@10 BUD: 1/27/2015; 20151407@11 BUD: 1/10/2015; 20151604@8 9/16/2015; 20152703@2 9/16/2015

Recall Number: D-0286-2016

Reason for Recall
Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.
Initiated
09-12-2015
Reported
11-25-2015
Quantity
13,843 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
72179
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.
US Compounding 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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-30-2017
Product Description About Product Description
Full technical description of the product.
Triamcinolone diacetate USP (40 mg/mL), 30 mL Multi-Dose Vial, For IM & Regional Injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3205-06

Batch or Lot Expiration Information

Lot# Lot: 20150204@7 BUD: 9/29/2015, 20150304@1 BUD: 9/29/2015, 20150604@23 BUD: 10/3/2015, 20150807@50 BUD: 1/4/2016, 20150906@23 BUD: 12/6/2015, 20150906@24 BUD: 12/6/2015, 20152005@42 BUD: 11/16/2015, 20152206@52 BUD: 12/19/2015, 20152406@14 BUD: 12/21/2015, 20152603@26 BUD: 9/22/2015, 20152804@20 BUD: 10/25/2015, 20152904@20 BUD: 10/26/2015, 20152907@8 BUD: 1/25/2016, 20151603@56 BUD: 9/12/2015, 20152406@30 BUD: 12/21/2015

Recall Number: D-0245-2016

Reason for Recall
Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.
Initiated
09-12-2015
Reported
11-25-2015
Quantity
1,198 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
72179
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.
US Compounding 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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-30-2017
Product Description About Product Description
Full technical description of the product.
Cyclo/PE/Tropic/Ketor (1%/2.5%/1%/0.5%), 10 mL Opthalmic dropper bottle, For topical ophthalmic use, Rx. only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3044-07

Batch or Lot Expiration Information

Lot# Lot Numbers: 20152707@22 BUD: 10/25/2015; 20150707@9 BUD: 10/5/2015; 20152906@15 BUD: 9/27/2015; 20152907@2 BUD: 10/27/2015

Recall Number: D-0276-2016

Reason for Recall
Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.
Initiated
09-12-2015
Reported
11-25-2015
Quantity
14,580 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
72179
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.
US Compounding 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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-30-2017
Product Description About Product Description
Full technical description of the product.
Phenylephrine PF (1 mg/10 mL), 10 mL Single Use Syringe, For IV Use, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3159-07

Batch or Lot Expiration Information

Lot# Lot Code: 20150806@1 BUD: 12/5/2015, 20150806@2 BUD: 12/5/2015, 20151105@4 BUD: 11/7/2015, 20151105@6 BUD: 11/7/2015, 20151407@3 BUD: 1/10/2016, 20151603@1 BUD: 9/12/2015, 20151805@25 BUD: 11/14/2015, 20151805@28 BUD: 11/14/2015, 20152206@17 BUD: 12/19/2015, 20152707@1 BUD: 1/23/2016, 20153003@1 BUD: 9/26/2015, 20152003@2 BUD: 9/26/2015

Recall Number: D-0262-2016

Reason for Recall
Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.
Initiated
09-12-2015
Reported
11-25-2015
Quantity
1,421 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
72179
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.
US Compounding 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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-30-2017
Product Description About Product Description
Full technical description of the product.
Lincomycin/Lidocaine (300 mg/1%/mL), 10 mL Multi-Dose Vial, For IV Injection or IV Injection After Dilution, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3104-07

Batch or Lot Expiration Information

Lot# Lot Numbers: 20150505@1 BUD: 10/31/2015

Recall Number: D-0283-2016

Reason for Recall
Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.
Initiated
09-12-2015
Reported
11-25-2015
Quantity
1,093 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
72179
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.
US Compounding 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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-30-2017
Product Description About Product Description
Full technical description of the product.
Trace Elements-4 (Zinc Sulfate heptahydrate 4.39 mg, Cupric Sulfate pentahydrate 1.57 mg, Manganese Sulfate monohydrate USP 0.308 mg, Chromic Chloride hexahydrate USP 0.0205 mg), 10 mL Multi-Dose Vial, For IV Injection After Dilution, Dilute Before IV Use, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72653, NDC 62295-3201-07

Batch or Lot Expiration Information

Lot# Lot Code: 20152804@35 BUD: 10/25/2015, 20150505@26 BUD: 11/1/2015

Recall Number: D-0285-2016

Reason for Recall
Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.
Initiated
09-12-2015
Reported
11-25-2015
Quantity
980 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
72179
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.
US Compounding 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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-30-2017
Product Description About Product Description
Full technical description of the product.
Triamcinolone/Lidocaine (40 mg/1%/mL), 10 mL Multidose Vial, For IM & Regional Injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72653, NDC 62295-3204-07

Batch or Lot Expiration Information

Lot# Lot Code: 20150204@18 BUD: 9/29/2015, 20150906@38 BUD: 12/6/2015

Recall Number: D-0253-2016

Reason for Recall
Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.
Initiated
09-12-2015
Reported
11-25-2015
Quantity
14,325 syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
72179
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.
US Compounding 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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-30-2017
Product Description About Product Description
Full technical description of the product.
Glycopyrrolate USP ( 1 mg/5 mL), 5 mL Single Use syringe, For IM or IV Injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3082-05

Batch or Lot Expiration Information

Lot# Lot Numbers: 20150306@57 BUD: 11/30/2015; 20151305@40 BUD: 11/9/2015; 20151404@36 BUD: 10/11/2015; 20151603@3 BUD: 9/12/2015; 20152005@40 BUD: 11/16/2015; 20153003@10 BUD: 9/26/2015

Recall Number: D-0293-2016

Reason for Recall
Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.
Initiated
09-12-2015
Reported
11-25-2015
Quantity
2 dropper bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
72179
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.
US Compounding 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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-30-2017
Product Description About Product Description
Full technical description of the product.
Voriconazole Solution (1%(10 mg/mL), 15 mL dropper bottle; For Topical Ophthalmic Use, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-2815-10

Batch or Lot Expiration Information

Lot# Lot Code: 20150209@40 BUD: 9/16/2015

Recall Number: D-0243-2016

Reason for Recall
Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.
Initiated
09-12-2015
Reported
11-25-2015
Quantity
589 vials.

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
72179
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.
US Compounding 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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-30-2017
Product Description About Product Description
Full technical description of the product.
Brompheniramine Maleate (10 mg/mL), 10 mL Multi-Dose Vial, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3019-07

Batch or Lot Expiration Information

Lot# Lot Numbers: 20151205@11 BUD: 11/7/2015; 20151806@11 BUD: 12/15/2015

Recall Number: D-0270-2016

Reason for Recall
Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.
Initiated
09-12-2015
Reported
11-25-2015
Quantity
5,919 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
72179
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.
US Compounding 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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-30-2017
Product Description About Product Description
Full technical description of the product.
Morphine PF (2 mg/2 mL), 2 mL Single Use Vial, For IV or IM Administration, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-2171-02

Batch or Lot Expiration Information

Lot# Lot Code: 20151008@2 BUD: 2/6/2016, 20151307@2 BUD: 1/9/2016, 20153107@27 BUD: 1/27/2016

Recall Number: D-0249-2016

Reason for Recall
Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.
Initiated
09-12-2015
Reported
11-25-2015
Quantity
854 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
72179
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.
US Compounding 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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-30-2017
Product Description About Product Description
Full technical description of the product.
Dex Combo (Dexamethasone acetate 8mg/mL, dexamethasone sodium phosphate USP, 4 mg/mL),30 mL Multi-Dose Vial, For IM & Regional Injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3057-06

Batch or Lot Expiration Information

Lot# Lot Numbers: 20150705@1 BUD: 11/2/2015; 20151706@49 BUD: 12/14/2015; 20152204@21 BUD: 10/19/2015; 20152303@26 BUD: 9/19/2015

Recall Number: D-0277-2016

Reason for Recall
Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.
Initiated
09-12-2015
Reported
11-25-2015
Quantity
3,860 dropper bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
72179
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.
US Compounding 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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-30-2017
Product Description About Product Description
Full technical description of the product.
Phenylephrine PF Sterile Solution (2.5%), 3 mL Single Use Ophthalmic Dropper For Topical Ophthalmic Use, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3272-03

Batch or Lot Expiration Information

Lot# Lot Code: 20150206@3 BUD: 11/29/2015, 20150306@51 BUD: 11/30/2015, 20151106@28 BUD: 12/8/2015, 20151404@4 BUD: 10/11/2015, 20151606@3 BUD: 12/13/2015

Recall Number: D-0269-2016

Reason for Recall
Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.
Initiated
09-12-2015
Reported
11-25-2015
Quantity
1,736 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
72179
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.
US Compounding 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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-30-2017
Product Description About Product Description
Full technical description of the product.
MIC-Combo, 30 mL Multi-Dose Vial, For Deep IM Injection Only, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3127-06.

Batch or Lot Expiration Information

Lot# Lot Code: 20150105@18 BUD: 10/28/2015, 20150805@34 BUD: 11/4/2015, 20152603@12 BUD: 9/21/2015, 20153004@20 BUD: 10/27/2015, 20150805@34 BUD: 11/4/2015, 20152603@12 BUD: 9/21/2015, 20153004@20 BUD: 10/27/2015

Recall Number: D-0260-2016

Reason for Recall
Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.
Initiated
09-12-2015
Reported
11-25-2015
Quantity
1,706 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
72179
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.
US Compounding 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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-30-2017
Product Description About Product Description
Full technical description of the product.
L-Cysteine PF (50 mg/mL), 10 mL Single Dose Vial, For IV Use After Dilution, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3239-01

Batch or Lot Expiration Information

Lot# Lot Numbers: 20151906@10 BUD: 9/17/2015

Recall Number: D-0247-2016

Reason for Recall
Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.
Initiated
09-12-2015
Reported
11-25-2015
Quantity
2,984 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
72179
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.
US Compounding 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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-30-2017
Product Description About Product Description
Full technical description of the product.
Dapiprazole (Diluent+Powder) 0.5% in 5 mL vial, For topical ophthalmic use, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-0201-99

Batch or Lot Expiration Information

Lot# Lot Numbers: 20150506@6 BUD: 11/28/2015; 20150805@40 BUD: 10/31/2015; 20151206@7 BUD: 12/5/2015; 20151704@21 BUD: 10/10/2015; 20152003@43 BUD: 9/12/2015

Recall Number: D-0257-2016

Reason for Recall
Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.
Initiated
09-12-2015
Reported
11-25-2015
Quantity
105 syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
72179
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.
US Compounding 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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-30-2017
Product Description About Product Description
Full technical description of the product.
Hyaluronic Acid/Lidocaine (20 mg/1%/2 mL), 3 mL Single Use Syringe, For Intra-Articular Injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3239-01

Batch or Lot Expiration Information

Lot# Lot Numbers: 20151806@30 BUD: 11/7/2015, 20152306@38 BUD: 11/7/2015, 20151806@29 BUD: 11/7/2015, 20151903@30 BUD: 9/15/2015

Recall Number: D-0280-2016

Reason for Recall
Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.
Initiated
09-12-2015
Reported
11-25-2015
Quantity
1,590 syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
72179
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.
US Compounding 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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-30-2017
Product Description About Product Description
Full technical description of the product.
Succinylcholine Chloride (200 mg/10 mL), 10 mL Single Use Syringe (20 mg/mL), For IV use, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72653, NDC 62295-3292-07

Batch or Lot Expiration Information

Lot# Lot Code: 20152606@4 BUD: 9/23/2015, 20151108@49 BUD: 11/9/2015

Recall Number: D-0274-2016

Reason for Recall
Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.
Initiated
09-12-2015
Reported
11-25-2015
Quantity
862 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
72179
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.
US Compounding 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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-30-2017
Product Description About Product Description
Full technical description of the product.
Phenylephrine 10% PF Ophthalmic Solution, 3 mL dropper bottle, For Topical Ophthalmic Use, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3273-03.

Batch or Lot Expiration Information

Lot# Lot Code: 20151803@4 BUD: 9/14/2015, 20152005@19 BUD: 11/16/2015, 20152307@15 BUD: 1/19/2016, 20153003@4 BUD: 9/26/2015

Recall Number: D-0256-2016

Reason for Recall
Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.
Initiated
09-12-2015
Reported
11-25-2015
Quantity
531 syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
72179
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.
US Compounding 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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-30-2017
Product Description About Product Description
Full technical description of the product.
Hyaluronic Acid/Lidocaine PF (60 mg/2%), 3 mL Single Use Syringe, For Intra-Articular Injection , Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3249-03

Batch or Lot Expiration Information

Lot# Lot Numbers: 20151105@39 BUD: 11/7/2015

Recall Number: D-0248-2016

Reason for Recall
Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.
Initiated
09-12-2015
Reported
11-25-2015
Quantity
4,333 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
72179
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.
US Compounding 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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-30-2017
Product Description About Product Description
Full technical description of the product.
Dex LA 8 (Dexamethasone acetate (8 mg/mL), 10 mL Multi-Dose Vial, For IM & Regional Injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3299-02

Batch or Lot Expiration Information

Lot# Lot Numbers: 20150107@23 BUD: 12/28/2015; 20151305@43 BUD: 11/9/2015; 20151307@18 BUD: 1/9/2016; 20152204@33 BUD: 10/19/2015; 20152606@1 BUD: 12/22/2015; 20153003@34 BUD: 9/26/2015

Recall Number: D-0289-2016

Reason for Recall
Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.
Initiated
09-12-2015
Reported
11-25-2015
Quantity
1,833 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
72179
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.
US Compounding 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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-30-2017
Product Description About Product Description
Full technical description of the product.
Tropicamide 0.5%/ Phenylephrine 5%, 2 mL Dropper Bottle For Topical Ophthalmic Use, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3298-02

Batch or Lot Expiration Information

Lot# Lot Code: 20151606@11 BUD: 12/13/2015

Recall Number: D-0244-2016

Reason for Recall
Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.
Initiated
09-12-2015
Reported
11-25-2015
Quantity
135 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
72179
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.
US Compounding 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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-30-2017
Product Description About Product Description
Full technical description of the product.
Cyclo/PE/Trop PF (1%/2.5%/1%), 3 mL dropper bottle, For topical ophthalmic use, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3049-03

Batch or Lot Expiration Information

Lot# Lot Numbers: 20150707@5 BUD: 1/3/2016

Recall Number: D-0240-2016

Reason for Recall
Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.
Initiated
09-12-2015
Reported
11-25-2015
Quantity
100 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
72179
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.
US Compounding 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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-30-2017
Product Description About Product Description
Full technical description of the product.
Betamethasone SP, 2 mL (6 mg/mL),10 mL Multi-Dose Vial, For IM & Regional Injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3240-07

Batch or Lot Expiration Information

Lot# Lot Numbers: 20150806@9 BUD: 12/5/2015; 20152107@38 BUD: 1/17/2016

Recall Number: D-0278-2016

Reason for Recall
Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.
Initiated
09-12-2015
Reported
11-25-2015
Quantity
2 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
72179
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.
US Compounding 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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-30-2017
Product Description About Product Description
Full technical description of the product.
Pilocarpine (1/16%) Ophthalmic, 15 mL dropper bottle, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72653

Batch or Lot Expiration Information

Lot# Lot Code: 20152406@3 BUD: 9/12/2015, 20153108@16 BUD: 11/29/2015

Recall Number: D-0287-2016

Reason for Recall
Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.
Initiated
09-12-2015
Reported
11-25-2015
Quantity
33,778 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
72179
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.
US Compounding 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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-30-2017
Product Description About Product Description
Full technical description of the product.
Triamcinolone diacetate USP PF (40 mg/mL), 2 mL Vial, For IM & Regional Injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3206-01

Batch or Lot Expiration Information

Lot# Lot Code: 20150608@19 BUD: 2/2/2016, 20150807@35 BUD: 1/4/2016, 20152104@12 BUD: 10/1//2015, 20150105@2 BUD: 10/28/2015, 20150605@36 BUD: 11/2/2015, 20150607@26 BUD: 1/2/2016, 20150904@32 BUD: 10/6/2015, 20150906@35 BUD: 12/6/2015, 20151506@45 BUD: 12/12/2015, 20151603@43 BUD: 9/12/2015, 20152204@15 BUD: 10/19/2015, 20152506@35 BUD: 12/22/2015, 20152907@1 BUD: 1/25/2016

Recall Number: D-0255-2016

Reason for Recall
Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.
Initiated
09-12-2015
Reported
11-25-2015
Quantity
5,118 syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
72179
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.
US Compounding 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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-30-2017
Product Description About Product Description
Full technical description of the product.
Hyaluronic Acid/Lidocaine PF (20 mg/1%), 2 mL Single-Use Syringe , For Intra-Articular Injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3087-02

Batch or Lot Expiration Information

Lot# Lot Numbers: 20150906@32 BUD: 12/6/2015, 20150906@33 BUD: 12/6/2015, 20151105@45 BUD: 11/7/2015, 20151205@12 BUD: 11/8/2015, 20151404@39 BUD: 10/11/2015

Recall Number: D-0275-2016

Reason for Recall
Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.
Initiated
09-12-2015
Reported
11-25-2015
Quantity
11 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
72179
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.
US Compounding 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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-30-2017
Product Description About Product Description
Full technical description of the product.
Phenylephrine (1 mg/mL), 5 mL Multi-Dose Vial, For SC, IM, IV or penile injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3289-05

Batch or Lot Expiration Information

Lot# Lot Code: 20150904@11 BUD: 10/6/2015

Recall Number: D-0281-2016

Reason for Recall
Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.
Initiated
09-12-2015
Reported
11-25-2015
Quantity
2,524 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
72179
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.
US Compounding 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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-30-2017
Product Description About Product Description
Full technical description of the product.
Testosterone cypionate, USP (250 mg/mL), 10 mL Multi-Dose Vial, For Deep IM Injection Only, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72653, NDC 62295-2131-07

Batch or Lot Expiration Information

Lot# Lot Code: 20150306@41 BUD: 11/30/2015, 20150505@56 BUD: 11/1/2015, 20150605@21 BUD: 11/2/2015, 20151607@33 BUD: 1/12/2015, 20152104@9 BUD: 10/18/2015, 20152206@24 BUD: 12/19/2015, 20151404@26 BUD: 10/11/2015, 20152104@9 BUD: 10/18/2015

Recall Number: D-0284-2016

Reason for Recall
Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.
Initiated
09-12-2015
Reported
11-25-2015
Quantity
1,244 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
72179
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.
US Compounding 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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-30-2017
Product Description About Product Description
Full technical description of the product.
Triamcinolone acetonide, USP (50 mg/mL), 10 mL Multi-Dose Vial, For IM & Regional Injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72653, NDC 62295-3203-07

Batch or Lot Expiration Information

Lot# Lot Code: 20150605@28 BUD: 11/2/2015, 20150607@38 BUD: 1/2/2016, 20150906@3 BUD: 12/6/2015

Recall Number: D-0238-2016

Reason for Recall
Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.
Initiated
09-12-2015
Reported
11-25-2015
Quantity
19,494 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
72179
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.
US Compounding 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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-30-2017
Product Description About Product Description
Full technical description of the product.
Betamethasone Combo 10 mL (7 mg/mL), 10 mL Multi-Dose Vial,for IM & Regional Injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3018-10

Batch or Lot Expiration Information

Lot# Lot Numbers: 20150104@4 BUD: 9/27/2015; 20150105@1 BUD: 10/27/2015; 20150107@25 BUD: 12/27/2015; 20150306@44 BUD: 11/29/2015; 20150704@49 BUD: 10/3/2015; 20150705@5 BUD: 11/1/2015; 20151106@17 BUD: 12/7/2015; 20151305@5 BUD: 11/8/2015; 20151806@19 BUD: 12/13/2015; 20152005@29 BUD: 11/15/2015; 20152205@7 BUD: 11/16/2015

Recall Number: D-0288-2016

Reason for Recall
Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.
Initiated
09-12-2015
Reported
11-25-2015
Quantity
797 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
72179
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.
US Compounding 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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-30-2017
Product Description About Product Description
Full technical description of the product.
Tri-Mix 30/1/10 (papaverine HCL USP 30 mg/ phentolamine mesylate USP 1 mg/ alprostadil USP 10 mcg/mL), 5 mL Multi-Dose Vial, For Penile Injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3256-05

Batch or Lot Expiration Information

Lot# Lot Code: 20151305@17 BUD: 9/16/2015, 20151504@18 BUD: 9/16/2015, 20151903@13 BUD: 9/12/2015, 20151903@13 BUD: 9/12/2015, 20152107@3 BUD: 1/16/2016, 20152204@6 BUD: 9/16/2015, 20152403@13 BUD: 9/12/2015, 20152403@21 BUD: 9/16/2015, 20152904@8 BUD: 9/16/2015

Recall Number: D-0251-2016

Reason for Recall
Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.
Initiated
09-12-2015
Reported
11-25-2015
Quantity
12,191 syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
72179
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.
US Compounding 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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-30-2017
Product Description About Product Description
Full technical description of the product.
ePHEDrine Sulfate PF (50 mg/10 mL), 10 mL Single-Use Syringe, For IV or IM Use Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3084-07

Batch or Lot Expiration Information

Lot# Lot Numbers: 20151706@45 BUD: 12/14/2015; 20151707@16 BUD: 1/13/2016; 20150904@17 BUD: 10/6/2015; 20151703@19 BUD: 9/13/2015; 20153003@7 BUD: 9/26/2015; 20153006@42 BUD: 12/27/2015

Recall Number: D-0236-2016

Reason for Recall
Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.
Initiated
09-12-2015
Reported
11-25-2015
Quantity
3 dropper bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
72179
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.
US Compounding 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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-30-2017
Product Description About Product Description
Full technical description of the product.
ACETYLCYSTEINE 10% OPHTALMIC, 10 mL dropper bottle; For topical ophthalmic use, Rx.only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032.

Batch or Lot Expiration Information

Lot# Lot Numbers: 20150209@41 BUD: 10/2/2015, 20150909@2 BUD: 10/9/2015

Recall Number: D-0264-2016

Reason for Recall
Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.
Initiated
09-12-2015
Reported
11-25-2015
Quantity
265 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
72179
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.
US Compounding 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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-30-2017
Product Description About Product Description
Full technical description of the product.
Methylcobalamin (12.5 mg/mL), 2.5 mL Multi-Dose Vial, For IM or SC Injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3251-04.

Batch or Lot Expiration Information

Lot# Lot Numbers: 20152105@38 BUD: 11/17/2015, 20152705@34 BUD: 11/23/2015

Recall Number: D-0266-2016

Reason for Recall
Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.
Initiated
09-12-2015
Reported
11-25-2015
Quantity
22,627 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
72179
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.
US Compounding 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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-30-2017
Product Description About Product Description
Full technical description of the product.
MethylPREDNISolone PF (80 mg/mL), 1 mL Single Use Vial, For IM & Regional Injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3119-01.

Batch or Lot Expiration Information

Lot# Lot Numbers: 20150806@35 BUD: 12/5/2015, 20151006@34 BUD: 12/7/2015, 20152303@42 BUD: 9/19/2015, 20152704@16 BUD: 10/24/2015, 20152906@26 BUD: 12/26/2015, 20153007@19 BUD: 1/26/2016, 20151703@6 BUD: 9/13/2015, 20151806@12 BUD: 12/15/2015

Recall Number: D-0263-2016

Reason for Recall
Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.
Initiated
09-12-2015
Reported
11-25-2015
Quantity
439 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
72179
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.
US Compounding 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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-30-2017
Product Description About Product Description
Full technical description of the product.
MedroxyPROGESTERone/Lidocaine (150 mg/mL/1%) 10 mL Multi-Dose Vial, For IM Injection Only, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3113-07

Batch or Lot Expiration Information

Lot# Lot Numbers: 20150705@13 BUD: 11/3/2015, 20151805@36 BUD: 11/14/2015

Recall Number: D-0242-2016

Reason for Recall
Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.
Initiated
09-12-2015
Reported
11-25-2015
Quantity
96 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
72179
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.
US Compounding 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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-30-2017
Product Description About Product Description
Full technical description of the product.
Bi-Mix (Papaverine 30 mg/mL, Phentolamine 1 mg/mL), 5 mL Multi-Dose Vial, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3254-05

Batch or Lot Expiration Information

Lot# Lot Numbers: 20152303@7 BUD: 9/19/2015

Recall Number: D-0261-2016

Reason for Recall
Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.
Initiated
09-12-2015
Reported
11-25-2015
Quantity
7,320 syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
72179
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.
US Compounding 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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-30-2017
Product Description About Product Description
Full technical description of the product.
Lidocaine 1% PF(100 mg/10 mL),10 mL Single Use Syringe, For IV Injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3099-07

Batch or Lot Expiration Information

Lot# Lot Numbers: 20150104@21 BUD: 9/28/2015, 20150406@26 BUD: 12/1/2015, 20151704@1 BUD: 10/14/2015, 20152004@10 BUD: 10/17/2015

Recall Number: D-0290-2016

Reason for Recall
Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.
Initiated
09-12-2015
Reported
11-25-2015
Quantity
751 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
72179
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.
US Compounding 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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-30-2017
Product Description About Product Description
Full technical description of the product.
Tropicamide 1%/Phenylephrine 2.5% (tropicamide USP 10 mg/ phenylephrine HCL USP 25 mg), 10 mL Ophthalmic Dropper, For Topical Ophthalmic Use, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3214-07

Batch or Lot Expiration Information

Lot# Lot Code: 20151307@4 BUD: 1/9/2016, 20151805@30 BUD: 11/14/2015, 20152004@23 BUD: 10/17/2015

Recall Number: D-0272-2016

Reason for Recall
Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.
Initiated
09-12-2015
Reported
11-25-2015
Quantity
8,218 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
72179
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.
US Compounding 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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-30-2017
Product Description About Product Description
Full technical description of the product.
Omnipaque 300 (600 mg/2 mL), 2 mL Single Use Vial (300 mg/mL), For IV or IT Injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3137-02

Batch or Lot Expiration Information

Lot# Lot Code: 20150604@4 BUD: 10/3/2015, 20152205@1 BUD: 11/18/2015, 20152303@3 BUD: 9/19/2015, 20150604@1 BUD: 10/3/2015, 20151304@27 BUD: 9/19/2015, 20151506@19 BUD: 12/12/2015, 20151506@27R BUD: 11/28/2015, 20151603@2 BUD: 9/12/2015, 20152004@13 BUD: 10/17/2015, 20152206@13 BUD: 12/19/2015, 20152906@7 BUD: 12/26/2015

Recall Number: D-0252-2016

Reason for Recall
Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.
Initiated
09-12-2015
Reported
11-25-2015
Quantity
711 syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
72179
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.
US Compounding 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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-30-2017
Product Description About Product Description
Full technical description of the product.
Fentanyl PF 50 mL (25 mcg/mL), 10 mL Single Use Syringe, For IV, IM or SC injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-0002-50

Batch or Lot Expiration Information

Lot# Lot Numbers: 20150604@20 BUD: 10/3/2015; 20152306@20 BUD: 12/20/2015; 20152403@28 BUD: 9/20/2015

Recall Number: D-0291-2016

Reason for Recall
Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.
Initiated
09-12-2015
Reported
11-25-2015
Quantity
494 syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
72179
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.
US Compounding 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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-30-2017
Product Description About Product Description
Full technical description of the product.
Vancomycin Ophthalmic PF 0.5 mL (5 mg/0.5 mL (10 mg/mL), 1 mL syringe, For Topical Ophthalmic Use, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-0209-64

Batch or Lot Expiration Information

Lot# Lot Code: 20152306@13 BUD: 12/20/2015

Recall Number: D-0268-2016

Reason for Recall
Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.
Initiated
09-12-2015
Reported
11-25-2015
Quantity
1,939 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
72179
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.
US Compounding 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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-30-2017
Product Description About Product Description
Full technical description of the product.
MIC Combo (Methionine 25 mg/mL, Inositol 50 mg/mL, Choline chloride 50 mg/mL, Cyanocobalamin 1000 mcg/mL), 30 mL Multi-Dose Vial, For Deep IM Injection Only, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3127-06.

Batch or Lot Expiration Information

Lot# Lot Numbers: 20150705@32 BUD: 11/2/2015, 20151304@17 BUD: 10/10/2015, 20151905@56 BUD: 11/15/2015, 20152004@9 BUD: 10/17/2015

Recall Number: D-0265-2016

Reason for Recall
Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.
Initiated
09-12-2015
Reported
11-25-2015
Quantity
3,629 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
72179
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.
US Compounding 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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-30-2017
Product Description About Product Description
Full technical description of the product.
MethylPREDNISolone (100 mg/mL) 10 mL Multi-Dose Vial, For IM & Regional Injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3115-07

Batch or Lot Expiration Information

Lot# Lot Numbers: 20150806@41 BUD: 12/5/2015, 20151205@67 BUD: 11/8/2015, 20151504@24 BUD: 10/12/2015, 20152306@30 BUD: 12/20/2015, 20152603@27 BUD: 9/22/2015

Recall Number: D-0271-2016

Reason for Recall
Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.
Initiated
09-12-2015
Reported
11-25-2015
Quantity
15,640 syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
72179
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.
US Compounding 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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-30-2017
Product Description About Product Description
Full technical description of the product.
Neostigmine (5 mg/5 mL), 5 mL Single Use Syringe, For IM, SC or Slow IV Injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3132-05

Batch or Lot Expiration Information

Lot# Lot Code: 20150106@48 BUD: 11/28/2015, 20150106@49 BUD: 11/28/2015, 20150306@37 BUD: 11/30/2015, 20150906@50 BUD: 12/6/2015, 20150906@7 BUD: 12/5/2015, 20151208@32 BUD: 2/8/2016, 20152304@2 BUD: 10/20/2015, 20152804@6 BUD:10/24/2015

Recall Number: D-0279-2016

Reason for Recall
Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.
Initiated
09-12-2015
Reported
11-25-2015
Quantity
1 bottle

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
72179
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.
US Compounding 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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-30-2017
Product Description About Product Description
Full technical description of the product.
Prednisolone Sodium Phosphate PF Solution (1%) in 15 mL dropper bottle; For Topical Ophthalmic Use, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72653

Batch or Lot Expiration Information

Lot# Lot Code: 20150209@16 BUD: 10/2/2015

Recall Number: D-0282-2016

Reason for Recall
Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.
Initiated
09-12-2015
Reported
11-25-2015
Quantity
1,386 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
72179
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.
US Compounding 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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-30-2017
Product Description About Product Description
Full technical description of the product.
Testosterone EO-Pro-Cyp 220 (220 mg/mL) 30 mL Multi-Dose Vial, For Deep IM Injection Only, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72653, NDC 62295-2169-06

Batch or Lot Expiration Information

Lot# Lot Code: 20151006@46 BUD: 12/7/2015, 20151607@40 BUD: 1/12/2016, 20152005@32 BUD: 11/16/2015, 20152304@28 BUD: 10/20/2015, 20152304@5 BUD: 10/20/2015, 20152606@2 BUD: 12/22/2015, 20152907@16 BUD: 1/23/2016

Recall Number: D-0250-2016

Reason for Recall
Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.
Initiated
09-12-2015
Reported
11-25-2015
Quantity
235 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
72179
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.
US Compounding 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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-30-2017
Product Description About Product Description
Full technical description of the product.
Dexamethasone Sodium Phosphate PF (10 mg/mL), 2 mL Single Use Vial, For IV or IM Use Only, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3227-02

Batch or Lot Expiration Information

Lot# Lot Numbers: 20151407@13 BUD: 1/10/2016

Recall Number: D-0239-2016

Reason for Recall
Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.
Initiated
09-12-2015
Reported
11-25-2015
Quantity
5,514 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
72179
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.
US Compounding 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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-30-2017
Product Description About Product Description
Full technical description of the product.
Betamethasone Combo PF 2 mL (6 mg/mL) 10 mL Multi-Dose Vial, For IM & Regional Injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3018-02

Batch or Lot Expiration Information

Lot# Lot Numbers: 20150206@41 BUD: 11/28/2015; 20151603@58 BUD: 9/12/2015; 20152007@43 BUD: 1/16/2016; 20152104@41 BUD: 10/18/2015

Recall Number: D-0292-2016

Reason for Recall
Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.
Initiated
09-12-2015
Reported
11-25-2015
Quantity
55 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
72179
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.
US Compounding 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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-30-2017
Product Description About Product Description
Full technical description of the product.
Vitamin D3 in Olive Oil (50,000 IU/mL) 30 mL vial, For IM Use only, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3277-06

Batch or Lot Expiration Information

Lot# Lot Code: 20151703@26 BUD: 9/13/2015, 20151703@26 BUD: 9/13/2015

Recall Number: D-0259-2016

Reason for Recall
Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.
Initiated
09-12-2015
Reported
11-25-2015
Quantity
103 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
72179
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.
US Compounding 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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-30-2017
Product Description About Product Description
Full technical description of the product.
Choline chloride 50 mg/mL, Inositol 50 mg/mL Cyanocobalamin 1000 mcg/mL, 30 mL Multi-Dose Vial, For Deep IM Injection Only, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3294-06

Batch or Lot Expiration Information

Lot# Lot Numbers: 20150405@59 BUD: 10/31/2015

Recall Number: D-0258-2016

Reason for Recall
Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.
Initiated
09-12-2015
Reported
11-25-2015
Quantity
1,096 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
72179
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.
US Compounding 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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-30-2017
Product Description About Product Description
Full technical description of the product.
Hyaluronidase PF (150 units/mL) in 1 mL Single-Use Vial, Not for IV Use, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3239-01

Batch or Lot Expiration Information

Lot# Lot Numbers: 20150608@1 BUD: 10/5/2015, 20152707@4 BUD: 9/23/2015

Recall Number: D-0294-2016

Reason for Recall
Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.
Initiated
09-12-2015
Reported
11-25-2015
Quantity
562 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
72179
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.
US Compounding 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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-30-2017
Product Description About Product Description
Full technical description of the product.
Zinc Sulfate (1 mg/mL), 10 mL Single Dose Vial, For IV Use After Dilution, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3226-07

Batch or Lot Expiration Information

Lot# Lot Code: 20150804@1 BUD: 10/5/2015, 20150907@1 BUD: 1/5/2016

Recall Number: D-0246-2016

Reason for Recall
Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.
Initiated
09-12-2015
Reported
11-25-2015
Quantity
820 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
72179
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.
US Compounding 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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-30-2017
Product Description About Product Description
Full technical description of the product.
Cyclopent/PE/Tropic 2mL (1%/2.5%/0.25%), 2 mL dropper bottles; For topical ophthalmic use, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3299-02

Batch or Lot Expiration Information

Lot# Lot Numbers: 20151806@22 BUD: 12/15/2015; 20152306@36 BUD: 12/20/2015

Recall Number: D-0241-2016

Reason for Recall
Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.
Initiated
09-12-2015
Reported
11-25-2015
Quantity
6,008 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
72179
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.
US Compounding 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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-30-2017
Product Description About Product Description
Full technical description of the product.
Betamethasone SP PF (12 mg/mL), 2 mL Single Dose Vial, For IM & Regional Injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3016-02

Batch or Lot Expiration Information

Lot# Lot Numbers: 20150107@27 BUD:12/28/2015; 20150704@5 BUD: 10/4/2015; 20152005@22 BUD: 11/16/2015

Recall Number: D-0267-2016

Reason for Recall
Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.
Initiated
09-12-2015
Reported
11-25-2015
Quantity
11,363 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
72179
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.
US Compounding 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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-30-2017
Product Description About Product Description
Full technical description of the product.
Methylprednisolone/Lidocaine (40 mg/mL/1%) 10 mL Multi-Dose Vial, For IM & Regional Injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3122-07

Batch or Lot Expiration Information

Lot# Lot Numbers: 20150707@31 BUD: 1/3/2016, 20150707@36 BUD: 1/3/2016, 20151106@19 BUD: 12/8/2015, 20151604@24 BUD: 10/13/2015, 20151606@20 BUD: 12/13/2015, 20151805@60 BUD: 11/14/2015, 20152105@35 BUD: 11/17/2015, 20153103@13 BUD: 9/27/2015