Multi-event March 2016 FDA Recall Drug by Reliable Rexall-a Compounding Pharmacy

This Multi-event Class II drug recall was voluntarily initiated by Reliable Rexall-a Compounding Pharmacy on March 25, 2016 for the product Drug. The FDA reported the reason for recall as lack of processing controls. The product was distributed in U.S. Including: CA, HI, NM and the recall is currently terminated.

Reported Recall Events

D-1121-2016 TERMINATED D-1103-2016 TERMINATED D-1106-2016 TERMINATED D-1072-2016 TERMINATED D-1075-2016 TERMINATED D-1131-2016 TERMINATED D-1124-2016 TERMINATED D-1130-2016 TERMINATED D-1117-2016 TERMINATED D-1088-2016 TERMINATED D-1069-2016 TERMINATED D-1085-2016 TERMINATED D-1081-2016 TERMINATED D-1120-2016 TERMINATED D-1109-2016 TERMINATED D-1101-2016 TERMINATED D-1097-2016 TERMINATED D-1068-2016 TERMINATED D-1095-2016 TERMINATED D-1078-2016 TERMINATED D-1102-2016 TERMINATED D-1100-2016 TERMINATED D-1125-2016 TERMINATED D-1092-2016 TERMINATED D-1113-2016 TERMINATED D-1136-2016 TERMINATED D-1134-2016 TERMINATED D-1123-2016 TERMINATED D-1096-2016 TERMINATED D-1115-2016 TERMINATED D-1090-2016 TERMINATED D-1093-2016 TERMINATED D-1086-2016 TERMINATED D-1099-2016 TERMINATED D-1083-2016 TERMINATED D-1112-2016 TERMINATED D-1119-2016 TERMINATED D-1104-2016 TERMINATED D-1079-2016 TERMINATED D-1071-2016 TERMINATED D-1133-2016 TERMINATED D-1135-2016 TERMINATED D-1110-2016 TERMINATED D-1118-2016 TERMINATED D-1077-2016 TERMINATED D-1129-2016 TERMINATED D-1122-2016 TERMINATED D-1128-2016 TERMINATED D-1098-2016 TERMINATED D-1105-2016 TERMINATED D-1116-2016 TERMINATED D-1074-2016 TERMINATED D-1107-2016 TERMINATED D-1089-2016 TERMINATED D-1108-2016 TERMINATED D-1091-2016 TERMINATED D-1084-2016 TERMINATED D-1073-2016 TERMINATED D-1087-2016 TERMINATED D-1080-2016 TERMINATED D-1127-2016 TERMINATED D-1067-2016 TERMINATED D-1132-2016 TERMINATED D-1076-2016 TERMINATED D-1111-2016 TERMINATED D-1114-2016 TERMINATED D-1126-2016 TERMINATED D-1094-2016 TERMINATED D-1070-2016 TERMINATED D-1082-2016 TERMINATED

Recall Number: D-1121-2016

Reason for Recall
Lack of Processing Controls
Initiated
03-25-2016
Reported
07-13-2016
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
73662
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.
Reliable Rexall-A Compounding Pharmacy
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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S. Including: CA, HI, NM
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-10-2017
Product Description About Product Description
Full technical description of the product.
All fluconazole Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.

Batch or Lot Expiration Information

Lot# All lots compounded between 03/24/2015 and 03/24/2016 and within expiry.

Recall Number: D-1103-2016

Reason for Recall
Lack of Processing Controls
Initiated
03-25-2016
Reported
07-13-2016
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
73662
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.
Reliable Rexall-A Compounding Pharmacy
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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S. Including: CA, HI, NM
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-10-2017
Product Description About Product Description
Full technical description of the product.
All lidocaine, meloxicam, diclofenac and baclofen Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.

Batch or Lot Expiration Information

Lot# All lots compounded between 03/24/2015 and 03/24/2016 and within expiry.

Recall Number: D-1106-2016

Reason for Recall
Lack of Processing Controls
Initiated
03-25-2016
Reported
07-13-2016
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
73662
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.
Reliable Rexall-A Compounding Pharmacy
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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S. Including: CA, HI, NM
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-10-2017
Product Description About Product Description
Full technical description of the product.
All mirtazapine Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.

Batch or Lot Expiration Information

Lot# All lots compounded between 03/24/2015 and 03/24/2016 and within expiry.

Recall Number: D-1072-2016

Reason for Recall
Lack of Processing Controls
Initiated
03-25-2016
Reported
07-13-2016
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
73662
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.
Reliable Rexall-A Compounding Pharmacy
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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S. Including: CA, HI, NM
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-10-2017
Product Description About Product Description
Full technical description of the product.
All Peterson Cream Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.

Batch or Lot Expiration Information

Lot# All lots compounded between 03/24/2015 and 03/24/2016 and within expiry.

Recall Number: D-1075-2016

Reason for Recall
Lack of Processing Controls
Initiated
03-25-2016
Reported
07-13-2016
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
73662
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.
Reliable Rexall-A Compounding Pharmacy
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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S. Including: CA, HI, NM
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-10-2017
Product Description About Product Description
Full technical description of the product.
All monobenzone Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.

Batch or Lot Expiration Information

Lot# All lots compounded between 03/24/2015 and 03/24/2016 and within expiry.

Recall Number: D-1131-2016

Reason for Recall
Lack of Processing Controls
Initiated
03-25-2016
Reported
07-13-2016
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
73662
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.
Reliable Rexall-A Compounding Pharmacy
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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S. Including: CA, HI, NM
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-10-2017
Product Description About Product Description
Full technical description of the product.
All tacrolimus Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.

Batch or Lot Expiration Information

Lot# All lots compounded between 03/24/2015 and 03/24/2016 and within expiry..

Recall Number: D-1124-2016

Reason for Recall
Lack of Processing Controls
Initiated
03-25-2016
Reported
07-13-2016
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
73662
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.
Reliable Rexall-A Compounding Pharmacy
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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S. Including: CA, HI, NM
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-10-2017
Product Description About Product Description
Full technical description of the product.
All dyclonine Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.

Batch or Lot Expiration Information

Lot# All lots compounded between 03/24/2015 and 03/24/2016 and within expiry.

Recall Number: D-1130-2016

Reason for Recall
Lack of Processing Controls
Initiated
03-25-2016
Reported
07-13-2016
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
73662
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.
Reliable Rexall-A Compounding Pharmacy
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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S. Including: CA, HI, NM
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-10-2017
Product Description About Product Description
Full technical description of the product.
All Nitro Paste (nitroglycerin) Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.

Batch or Lot Expiration Information

Lot# All lots compounded between 03/24/2015 and 03/24/2016 and within expiry.

Recall Number: D-1117-2016

Reason for Recall
Lack of Processing Controls
Initiated
03-25-2016
Reported
07-13-2016
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
73662
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.
Reliable Rexall-A Compounding Pharmacy
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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S. Including: CA, HI, NM
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-10-2017
Product Description About Product Description
Full technical description of the product.
All cocaine Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.

Batch or Lot Expiration Information

Lot# All lots compounded between 03/24/2015 and 03/24/2016 and within expiry.

Recall Number: D-1088-2016

Reason for Recall
Lack of Processing Controls
Initiated
03-25-2016
Reported
07-13-2016
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
73662
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.
Reliable Rexall-A Compounding Pharmacy
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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S. Including: CA, HI, NM
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-10-2017
Product Description About Product Description
Full technical description of the product.
All hydroxyzine Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.

Batch or Lot Expiration Information

Lot# All lots compounded between 03/24/2015 and 03/24/2016 and within expiry.

Recall Number: D-1069-2016

Reason for Recall
Lack of Processing Controls
Initiated
03-25-2016
Reported
07-13-2016
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
73662
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.
Reliable Rexall-A Compounding Pharmacy
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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S. Including: CA, HI, NM
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-10-2017
Product Description About Product Description
Full technical description of the product.
All testosterone Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.

Batch or Lot Expiration Information

Lot# All lots compounded between 03/24/2015 and 03/24/2016 and within expiry.

Recall Number: D-1085-2016

Reason for Recall
Lack of Processing Controls
Initiated
03-25-2016
Reported
07-13-2016
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
73662
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.
Reliable Rexall-A Compounding Pharmacy
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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S. Including: CA, HI, NM
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-10-2017
Product Description About Product Description
Full technical description of the product.
All arginine Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.

Batch or Lot Expiration Information

Lot# All lots compounded between 03/24/2015 and 03/24/2016 and within expiry.

Recall Number: D-1081-2016

Reason for Recall
Lack of Processing Controls
Initiated
03-25-2016
Reported
07-13-2016
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
73662
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.
Reliable Rexall-A Compounding Pharmacy
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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S. Including: CA, HI, NM
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-10-2017
Product Description About Product Description
Full technical description of the product.
All tetracaine Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.

Batch or Lot Expiration Information

Lot# All lots compounded between 03/24/2015 and 03/24/2016 and within expiry.

Recall Number: D-1120-2016

Reason for Recall
Lack of Processing Controls
Initiated
03-25-2016
Reported
07-13-2016
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
73662
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.
Reliable Rexall-A Compounding Pharmacy
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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S. Including: CA, HI, NM
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-10-2017
Product Description About Product Description
Full technical description of the product.
All acyclovir and lidocaine Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.

Batch or Lot Expiration Information

Lot# All lots compounded between 03/24/2015 and 03/24/2016 and within expiry.

Recall Number: D-1109-2016

Reason for Recall
Lack of Processing Controls
Initiated
03-25-2016
Reported
07-13-2016
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
73662
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.
Reliable Rexall-A Compounding Pharmacy
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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S. Including: CA, HI, NM
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-10-2017
Product Description About Product Description
Full technical description of the product.
All sulfapyridine Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.

Batch or Lot Expiration Information

Lot# All lots compounded between 03/24/2015 and 03/24/2016 and within expiry.

Recall Number: D-1101-2016

Reason for Recall
Lack of Processing Controls
Initiated
03-25-2016
Reported
07-13-2016
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
73662
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.
Reliable Rexall-A Compounding Pharmacy
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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S. Including: CA, HI, NM
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-10-2017
Product Description About Product Description
Full technical description of the product.
All melatonin Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.

Batch or Lot Expiration Information

Lot# All lots compounded between 03/24/2015 and 03/24/2016 and within expiry.

Recall Number: D-1097-2016

Reason for Recall
Lack of Processing Controls
Initiated
03-25-2016
Reported
07-13-2016
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
73662
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.
Reliable Rexall-A Compounding Pharmacy
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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S. Including: CA, HI, NM
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-10-2017
Product Description About Product Description
Full technical description of the product.
All hydrocortisone Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.

Batch or Lot Expiration Information

Lot# All lots compounded between 03/24/2015 and 03/24/2016 and within expiry.

Recall Number: D-1068-2016

Reason for Recall
Labeling: Label Mix-Up: Products labeled Biotin 100 mg found to contain 4-aminopyridine
Initiated
03-25-2016
Reported
07-13-2016
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
73662
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Reliable Rexall-A Compounding Pharmacy
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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S. Including: CA, HI, NM
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-10-2017
Product Description About Product Description
Full technical description of the product.
CAP-BIOTIN 100 MG, Rx Only, Compounded by RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.

Batch or Lot Expiration Information

Lot# All lots compounded between 03/24/2015 and 03/24/2016 and within expiry.

Recall Number: D-1095-2016

Reason for Recall
Lack of Processing Controls
Initiated
03-25-2016
Reported
07-13-2016
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
73662
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.
Reliable Rexall-A Compounding Pharmacy
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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S. Including: CA, HI, NM
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-10-2017
Product Description About Product Description
Full technical description of the product.
All Stanford Magic Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.

Batch or Lot Expiration Information

Lot# All lots compounded between 03/24/2015 and 03/24/2016 and within expiry..

Recall Number: D-1078-2016

Reason for Recall
Lack of Processing Controls
Initiated
03-25-2016
Reported
07-13-2016
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
73662
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.
Reliable Rexall-A Compounding Pharmacy
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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S. Including: CA, HI, NM
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-10-2017
Product Description About Product Description
Full technical description of the product.
All fluocinonide Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.

Batch or Lot Expiration Information

Lot# All lots compounded between 03/24/2015 and 03/24/2016 and within expiry.

Recall Number: D-1102-2016

Reason for Recall
Lack of Processing Controls
Initiated
03-25-2016
Reported
07-13-2016
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
73662
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.
Reliable Rexall-A Compounding Pharmacy
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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S. Including: CA, HI, NM
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-10-2017
Product Description About Product Description
Full technical description of the product.
All triamcinolone Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.

Batch or Lot Expiration Information

Lot# All lots compounded between 03/24/2015 and 03/24/2016 and within expiry.

Recall Number: D-1100-2016

Reason for Recall
Lack of Processing Controls
Initiated
03-25-2016
Reported
07-13-2016
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
73662
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.
Reliable Rexall-A Compounding Pharmacy
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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S. Including: CA, HI, NM
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-10-2017
Product Description About Product Description
Full technical description of the product.
All nifedipine Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.

Batch or Lot Expiration Information

Lot# All lots compounded between 03/24/2015 and 03/24/2016 and within expiry.

Recall Number: D-1125-2016

Reason for Recall
Lack of Processing Controls
Initiated
03-25-2016
Reported
07-13-2016
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
73662
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.
Reliable Rexall-A Compounding Pharmacy
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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S. Including: CA, HI, NM
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-10-2017
Product Description About Product Description
Full technical description of the product.
All estradiol Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.

Batch or Lot Expiration Information

Lot# All lots compounded between 03/24/2015 and 03/24/2016 and within expiry.

Recall Number: D-1092-2016

Reason for Recall
Lack of Processing Controls
Initiated
03-25-2016
Reported
07-13-2016
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
73662
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.
Reliable Rexall-A Compounding Pharmacy
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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S. Including: CA, HI, NM
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-10-2017
Product Description About Product Description
Full technical description of the product.
All minocycline Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.

Batch or Lot Expiration Information

Lot# All lots compounded between 03/24/2015 and 03/24/2016 and within expiry.

Recall Number: D-1113-2016

Reason for Recall
Lack of Processing Controls
Initiated
03-25-2016
Reported
07-13-2016
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
73662
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.
Reliable Rexall-A Compounding Pharmacy
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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S. Including: CA, HI, NM
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-10-2017
Product Description About Product Description
Full technical description of the product.
All phenylephrine Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.

Batch or Lot Expiration Information

Lot# All lots compounded between 03/24/2015 and 03/24/2016 and within expiry.

Recall Number: D-1136-2016

Reason for Recall
Lack of Processing Controls
Initiated
03-25-2016
Reported
07-13-2016
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
73662
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.
Reliable Rexall-A Compounding Pharmacy
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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S. Including: CA, HI, NM
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-10-2017
Product Description About Product Description
Full technical description of the product.
All Malarone (atovaquone and proguanil) Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.

Batch or Lot Expiration Information

Lot# All lots compounded between 03/24/2015 and 03/24/2016 and within expiry..

Recall Number: D-1134-2016

Reason for Recall
Lack of Processing Controls
Initiated
03-25-2016
Reported
07-13-2016
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
73662
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.
Reliable Rexall-A Compounding Pharmacy
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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S. Including: CA, HI, NM
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-10-2017
Product Description About Product Description
Full technical description of the product.
All baclofen Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.

Batch or Lot Expiration Information

Lot# All lots compounded between 03/24/2015 and 03/24/2016 and within expiry.

Recall Number: D-1123-2016

Reason for Recall
Lack of Processing Controls
Initiated
03-25-2016
Reported
07-13-2016
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
73662
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.
Reliable Rexall-A Compounding Pharmacy
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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S. Including: CA, HI, NM
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-10-2017
Product Description About Product Description
Full technical description of the product.
All doxycycline Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.

Batch or Lot Expiration Information

Lot# All lots compounded between 03/24/2015 and 03/24/2016 and within expiry.

Recall Number: D-1096-2016

Reason for Recall
Lack of Processing Controls
Initiated
03-25-2016
Reported
07-13-2016
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
73662
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.
Reliable Rexall-A Compounding Pharmacy
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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S. Including: CA, HI, NM
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-10-2017
Product Description About Product Description
Full technical description of the product.
All Jack Newman Cream Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.

Batch or Lot Expiration Information

Lot# All lots compounded between 03/24/2015 and 03/24/2016 and within expiry.

Recall Number: D-1115-2016

Reason for Recall
Lack of Processing Controls
Initiated
03-25-2016
Reported
07-13-2016
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
73662
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.
Reliable Rexall-A Compounding Pharmacy
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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S. Including: CA, HI, NM
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-10-2017
Product Description About Product Description
Full technical description of the product.
All quinacrine Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.

Batch or Lot Expiration Information

Lot# All lots compounded between 03/24/2015 and 03/24/2016 and within expiry.

Recall Number: D-1090-2016

Reason for Recall
Lack of Processing Controls
Initiated
03-25-2016
Reported
07-13-2016
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
73662
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.
Reliable Rexall-A Compounding Pharmacy
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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S. Including: CA, HI, NM
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-10-2017
Product Description About Product Description
Full technical description of the product.
All citalopram Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.

Batch or Lot Expiration Information

Lot# All lots compounded between 03/24/2015 and 03/24/2016 and within expiry.

Recall Number: D-1093-2016

Reason for Recall
Lack of Processing Controls
Initiated
03-25-2016
Reported
07-13-2016
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
73662
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.
Reliable Rexall-A Compounding Pharmacy
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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S. Including: CA, HI, NM
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-10-2017
Product Description About Product Description
Full technical description of the product.
All lidocaine/tetracaine/benzocaine Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.

Batch or Lot Expiration Information

Lot# All lots compounded between 03/24/2015 and 03/24/2016 and within expiry.

Recall Number: D-1086-2016

Reason for Recall
Lack of Processing Controls
Initiated
03-25-2016
Reported
07-13-2016
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
73662
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.
Reliable Rexall-A Compounding Pharmacy
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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S. Including: CA, HI, NM
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-10-2017
Product Description About Product Description
Full technical description of the product.
All cetirizine Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.

Batch or Lot Expiration Information

Lot# All lots compounded between 03/24/2015 and 03/24/2016 and within expiry..

Recall Number: D-1099-2016

Reason for Recall
Lack of Processing Controls
Initiated
03-25-2016
Reported
07-13-2016
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
73662
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.
Reliable Rexall-A Compounding Pharmacy
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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S. Including: CA, HI, NM
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-10-2017
Product Description About Product Description
Full technical description of the product.
All naltrexone Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.

Batch or Lot Expiration Information

Lot# All lots compounded between 03/24/2015 and 03/24/2016 and within expiry.

Recall Number: D-1083-2016

Reason for Recall
Lack of Processing Controls
Initiated
03-25-2016
Reported
07-13-2016
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
73662
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.
Reliable Rexall-A Compounding Pharmacy
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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S. Including: CA, HI, NM
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-10-2017
Product Description About Product Description
Full technical description of the product.
All thymol Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.

Batch or Lot Expiration Information

Lot# All lots compounded between 03/24/2015 and 03/24/2016 and within expiry.

Recall Number: D-1112-2016

Reason for Recall
Lack of Processing Controls
Initiated
03-25-2016
Reported
07-13-2016
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
73662
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.
Reliable Rexall-A Compounding Pharmacy
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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S. Including: CA, HI, NM
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-10-2017
Product Description About Product Description
Full technical description of the product.
All Coal Tar Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.

Batch or Lot Expiration Information

Lot# All lots compounded between 03/24/2015 and 03/24/2016 and within expiry.

Recall Number: D-1119-2016

Reason for Recall
Lack of Processing Controls
Initiated
03-25-2016
Reported
07-13-2016
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
73662
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.
Reliable Rexall-A Compounding Pharmacy
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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S. Including: CA, HI, NM
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-10-2017
Product Description About Product Description
Full technical description of the product.
All hydroxyurea Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.

Batch or Lot Expiration Information

Lot# All lots compounded between 03/24/2015 and 03/24/2016 and within expiry.

Recall Number: D-1104-2016

Reason for Recall
Lack of Processing Controls
Initiated
03-25-2016
Reported
07-13-2016
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
73662
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.
Reliable Rexall-A Compounding Pharmacy
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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S. Including: CA, HI, NM
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-10-2017
Product Description About Product Description
Full technical description of the product.
All thyroid Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.

Batch or Lot Expiration Information

Lot# All lots compounded between 03/24/2015 and 03/24/2016 and within expiry.

Recall Number: D-1079-2016

Reason for Recall
Lack of Processing Controls
Initiated
03-25-2016
Reported
07-13-2016
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
73662
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.
Reliable Rexall-A Compounding Pharmacy
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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S. Including: CA, HI, NM
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-10-2017
Product Description About Product Description
Full technical description of the product.
All methimazole Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.

Batch or Lot Expiration Information

Lot# All lots compounded between 03/24/2015 and 03/24/2016 and within expiry.

Recall Number: D-1071-2016

Reason for Recall
Lack of Processing Controls
Initiated
03-25-2016
Reported
07-13-2016
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
73662
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.
Reliable Rexall-A Compounding Pharmacy
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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S. Including: CA, HI, NM
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-10-2017
Product Description About Product Description
Full technical description of the product.
All TRIE Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.

Batch or Lot Expiration Information

Lot# All lots compounded between 03/24/2015 and 03/24/2016 and within expiry.

Recall Number: D-1133-2016

Reason for Recall
Lack of Processing Controls
Initiated
03-25-2016
Reported
07-13-2016
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
73662
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.
Reliable Rexall-A Compounding Pharmacy
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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S. Including: CA, HI, NM
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-10-2017
Product Description About Product Description
Full technical description of the product.
All diethylstilbestrol Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.

Batch or Lot Expiration Information

Lot# All lots compounded between 03/24/2015 and 03/24/2016 and within expiry.

Recall Number: D-1135-2016

Reason for Recall
Lack of Processing Controls
Initiated
03-25-2016
Reported
07-13-2016
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
73662
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.
Reliable Rexall-A Compounding Pharmacy
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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S. Including: CA, HI, NM
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-10-2017
Product Description About Product Description
Full technical description of the product.
All potassium bromide Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.

Batch or Lot Expiration Information

Lot# All lots compounded between 03/24/2015 and 03/24/2016 and within expiry.

Recall Number: D-1110-2016

Reason for Recall
Lack of Processing Controls
Initiated
03-25-2016
Reported
07-13-2016
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
73662
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.
Reliable Rexall-A Compounding Pharmacy
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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S. Including: CA, HI, NM
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-10-2017
Product Description About Product Description
Full technical description of the product.
All Midrin (isometheptene mucate, dichloralphenazone and acetaminophen) Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.

Batch or Lot Expiration Information

Lot# All lots compounded between 03/24/2015 and 03/24/2016 and within expiry.

Recall Number: D-1118-2016

Reason for Recall
Lack of Processing Controls
Initiated
03-25-2016
Reported
07-13-2016
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
73662
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.
Reliable Rexall-A Compounding Pharmacy
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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S. Including: CA, HI, NM
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-10-2017
Product Description About Product Description
Full technical description of the product.
All diltiazem Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.

Batch or Lot Expiration Information

Lot# All lots compounded between 03/24/2015 and 03/24/2016 and within expiry.

Recall Number: D-1077-2016

Reason for Recall
Lack of Processing Controls
Initiated
03-25-2016
Reported
07-13-2016
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
73662
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.
Reliable Rexall-A Compounding Pharmacy
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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S. Including: CA, HI, NM
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-10-2017
Product Description About Product Description
Full technical description of the product.
All Germall (diazolidinyl urea and iodopropynyl butylcarbamate) Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.

Batch or Lot Expiration Information

Lot# All lots compounded between 03/24/2015 and 03/24/2016 and within expiry.

Recall Number: D-1129-2016

Reason for Recall
Lack of Processing Controls
Initiated
03-25-2016
Reported
07-13-2016
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
73662
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.
Reliable Rexall-A Compounding Pharmacy
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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S. Including: CA, HI, NM
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-10-2017
Product Description About Product Description
Full technical description of the product.
All hydroquinone Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.

Batch or Lot Expiration Information

Lot# All lots compounded between 03/24/2015 and 03/24/2016 and within expiry.

Recall Number: D-1122-2016

Reason for Recall
Lack of Processing Controls
Initiated
03-25-2016
Reported
07-13-2016
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
73662
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.
Reliable Rexall-A Compounding Pharmacy
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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S. Including: CA, HI, NM
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-10-2017
Product Description About Product Description
Full technical description of the product.
All sucralfate Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.

Batch or Lot Expiration Information

Lot# All lots compounded between 03/24/2015 and 03/24/2016 and within expiry.

Recall Number: D-1128-2016

Reason for Recall
Lack of Processing Controls
Initiated
03-25-2016
Reported
07-13-2016
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
73662
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.
Reliable Rexall-A Compounding Pharmacy
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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S. Including: CA, HI, NM
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-10-2017
Product Description About Product Description
Full technical description of the product.
All clobetasol Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.

Batch or Lot Expiration Information

Lot# All lots compounded between 03/24/2015 and 03/24/2016 and within expiry.

Recall Number: D-1098-2016

Reason for Recall
Lack of Processing Controls
Initiated
03-25-2016
Reported
07-13-2016
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
73662
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.
Reliable Rexall-A Compounding Pharmacy
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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S. Including: CA, HI, NM
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-10-2017
Product Description About Product Description
Full technical description of the product.
All spironolactone Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.

Batch or Lot Expiration Information

Lot# All lots compounded between 03/24/2015 and 03/24/2016 and within expiry.

Recall Number: D-1105-2016

Reason for Recall
Lack of Processing Controls
Initiated
03-25-2016
Reported
07-13-2016
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
73662
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.
Reliable Rexall-A Compounding Pharmacy
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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S. Including: CA, HI, NM
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-10-2017
Product Description About Product Description
Full technical description of the product.
All T3 Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.

Batch or Lot Expiration Information

Lot# All lots compounded between 03/24/2015 and 03/24/2016 and within expiry.

Recall Number: D-1116-2016

Reason for Recall
Lack of Processing Controls
Initiated
03-25-2016
Reported
07-13-2016
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
73662
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.
Reliable Rexall-A Compounding Pharmacy
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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S. Including: CA, HI, NM
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-10-2017
Product Description About Product Description
Full technical description of the product.
All capsicum Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.

Batch or Lot Expiration Information

Lot# All lots compounded between 03/24/2015 and 03/24/2016 and within expiry.

Recall Number: D-1074-2016

Reason for Recall
Lack of Processing Controls
Initiated
03-25-2016
Reported
07-13-2016
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
73662
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.
Reliable Rexall-A Compounding Pharmacy
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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S. Including: CA, HI, NM
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-10-2017
Product Description About Product Description
Full technical description of the product.
All carbomer Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.

Batch or Lot Expiration Information

Lot# All lots compounded between 03/24/2015 and 03/24/2016 and within expiry.

Recall Number: D-1107-2016

Reason for Recall
Lack of Processing Controls
Initiated
03-25-2016
Reported
07-13-2016
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
73662
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.
Reliable Rexall-A Compounding Pharmacy
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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S. Including: CA, HI, NM
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-10-2017
Product Description About Product Description
Full technical description of the product.
All ketoprofen Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.

Batch or Lot Expiration Information

Lot# All lots compounded between 03/24/2015 and 03/24/2016 and within expiry.

Recall Number: D-1089-2016

Reason for Recall
Lack of Processing Controls
Initiated
03-25-2016
Reported
07-13-2016
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
73662
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.
Reliable Rexall-A Compounding Pharmacy
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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S. Including: CA, HI, NM
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-10-2017
Product Description About Product Description
Full technical description of the product.
All quinine Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.

Batch or Lot Expiration Information

Lot# All lots compounded between 03/24/2015 and 03/24/2016 and within expiry.

Recall Number: D-1108-2016

Reason for Recall
Lack of Processing Controls
Initiated
03-25-2016
Reported
07-13-2016
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
73662
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.
Reliable Rexall-A Compounding Pharmacy
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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S. Including: CA, HI, NM
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-10-2017
Product Description About Product Description
Full technical description of the product.
All squaric acid Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.

Batch or Lot Expiration Information

Lot# All lots compounded between 03/24/2015 and 03/24/2016 and within expiry.

Recall Number: D-1091-2016

Reason for Recall
Lack of Processing Controls
Initiated
03-25-2016
Reported
07-13-2016
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
73662
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.
Reliable Rexall-A Compounding Pharmacy
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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S. Including: CA, HI, NM
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-10-2017
Product Description About Product Description
Full technical description of the product.
All fluoxymesterone Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.

Batch or Lot Expiration Information

Lot# All lots compounded between 03/24/2015 and 03/24/2016 and within expiry.

Recall Number: D-1084-2016

Reason for Recall
Lack of Processing Controls
Initiated
03-25-2016
Reported
07-13-2016
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
73662
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.
Reliable Rexall-A Compounding Pharmacy
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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S. Including: CA, HI, NM
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-10-2017
Product Description About Product Description
Full technical description of the product.
All T4-levothyroxine Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.

Batch or Lot Expiration Information

Lot# All lots compounded between 03/24/2015 and 03/24/2016 and within expiry.

Recall Number: D-1073-2016

Reason for Recall
Lack of Processing Controls
Initiated
03-25-2016
Reported
07-13-2016
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
73662
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.
Reliable Rexall-A Compounding Pharmacy
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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S. Including: CA, HI, NM
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-10-2017
Product Description About Product Description
Full technical description of the product.
All progesterone Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.

Batch or Lot Expiration Information

Lot# All lots compounded between 03/24/2015 and 03/24/2016 and within expiry..

Recall Number: D-1087-2016

Reason for Recall
Lack of Processing Controls
Initiated
03-25-2016
Reported
07-13-2016
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
73662
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.
Reliable Rexall-A Compounding Pharmacy
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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S. Including: CA, HI, NM
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-10-2017
Product Description About Product Description
Full technical description of the product.
All budesonide Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.

Batch or Lot Expiration Information

Lot# All lots compounded between 03/24/2015 and 03/24/2016 and within expiry.

Recall Number: D-1080-2016

Reason for Recall
Lack of Processing Controls
Initiated
03-25-2016
Reported
07-13-2016
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
73662
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.
Reliable Rexall-A Compounding Pharmacy
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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S. Including: CA, HI, NM
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-10-2017
Product Description About Product Description
Full technical description of the product.
All propylparaben Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.

Batch or Lot Expiration Information

Lot# All lots compounded between 03/24/2015 and 03/24/2016 and within expiry.

Recall Number: D-1127-2016

Reason for Recall
Lack of Processing Controls
Initiated
03-25-2016
Reported
07-13-2016
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
73662
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.
Reliable Rexall-A Compounding Pharmacy
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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S. Including: CA, HI, NM
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-10-2017
Product Description About Product Description
Full technical description of the product.
All methyltestosterone Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.

Batch or Lot Expiration Information

Lot# All lots compounded between 03/24/2015 and 03/24/2016 and within expiry.

Recall Number: D-1067-2016

Reason for Recall
Lack of Processing Controls
Initiated
03-25-2016
Reported
07-13-2016
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
73662
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.
Reliable Rexall-A Compounding Pharmacy
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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S. Including: CA, HI, NM
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-10-2017
Product Description About Product Description
Full technical description of the product.
All 4-aminopyridine Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.

Batch or Lot Expiration Information

Lot# All lots compounded between 03/24/2015 and 03/24/2016 and within expiry.

Recall Number: D-1132-2016

Reason for Recall
Lack of Processing Controls
Initiated
03-25-2016
Reported
07-13-2016
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
73662
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.
Reliable Rexall-A Compounding Pharmacy
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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S. Including: CA, HI, NM
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-10-2017
Product Description About Product Description
Full technical description of the product.
All e2-e3-p4 Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.

Batch or Lot Expiration Information

Lot# All lots compounded between 03/24/2015 and 03/24/2016 and within expiry.

Recall Number: D-1076-2016

Reason for Recall
Lack of Processing Controls
Initiated
03-25-2016
Reported
07-13-2016
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
73662
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.
Reliable Rexall-A Compounding Pharmacy
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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S. Including: CA, HI, NM
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-10-2017
Product Description About Product Description
Full technical description of the product.
All betamethasone diproprionate Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.

Batch or Lot Expiration Information

Lot# All lots compounded between 03/24/2015 and 03/24/2016 and within expiry.

Recall Number: D-1111-2016

Reason for Recall
Lack of Processing Controls
Initiated
03-25-2016
Reported
07-13-2016
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
73662
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.
Reliable Rexall-A Compounding Pharmacy
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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S. Including: CA, HI, NM
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-10-2017
Product Description About Product Description
Full technical description of the product.
All retinoic acid Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.

Batch or Lot Expiration Information

Lot# All lots compounded between 03/24/2015 and 03/24/2016 and within expiry.

Recall Number: D-1114-2016

Reason for Recall
Lack of Processing Controls
Initiated
03-25-2016
Reported
07-13-2016
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
73662
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.
Reliable Rexall-A Compounding Pharmacy
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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S. Including: CA, HI, NM
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-10-2017
Product Description About Product Description
Full technical description of the product.
All Arimidex (anastrozole) Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.

Batch or Lot Expiration Information

Lot# All lots compounded between 03/24/2015 and 03/24/2016 and within expiry.

Recall Number: D-1126-2016

Reason for Recall
Lack of Processing Controls
Initiated
03-25-2016
Reported
07-13-2016
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
73662
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.
Reliable Rexall-A Compounding Pharmacy
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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S. Including: CA, HI, NM
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-10-2017
Product Description About Product Description
Full technical description of the product.
All ketamine and amitriptyline Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.

Batch or Lot Expiration Information

Lot# All lots compounded between 03/24/2015 and 03/24/2016 and within expiry.

Recall Number: D-1094-2016

Reason for Recall
Lack of Processing Controls
Initiated
03-25-2016
Reported
07-13-2016
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
73662
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.
Reliable Rexall-A Compounding Pharmacy
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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S. Including: CA, HI, NM
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-10-2017
Product Description About Product Description
Full technical description of the product.
All boric acid Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.

Batch or Lot Expiration Information

Lot# All lots compounded between 03/24/2015 and 03/24/2016 and within expiry.

Recall Number: D-1070-2016

Reason for Recall
Lack of Processing Controls
Initiated
03-25-2016
Reported
07-13-2016
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
73662
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.
Reliable Rexall-A Compounding Pharmacy
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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S. Including: CA, HI, NM
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-10-2017
Product Description About Product Description
Full technical description of the product.
All estriol Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.

Batch or Lot Expiration Information

Lot# All lots compounded between 03/24/2015 and 03/24/2016 and within expiry.

Recall Number: D-1082-2016

Reason for Recall
Lack of Processing Controls
Initiated
03-25-2016
Reported
07-13-2016
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
73662
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.
Reliable Rexall-A Compounding Pharmacy
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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S. Including: CA, HI, NM
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-10-2017
Product Description About Product Description
Full technical description of the product.
All PCCA Lipoderm Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.

Batch or Lot Expiration Information

Lot# All lots compounded between 03/24/2015 and 03/24/2016 and within expiry.