Multi-event May 2016 FDA Recall Drug by Medaus, Inc.

This Multi-event Class II drug recall was voluntarily initiated by Medaus, Inc. on May 13, 2016 for the product Drug. The FDA reported the reason for recall as lack of assurance of sterility. The product was distributed Nationwide and the recall is currently terminated.

Reported Recall Events

D-1172-2016 TERMINATED D-1171-2016 TERMINATED D-1231-2016 TERMINATED D-1203-2016 TERMINATED D-1184-2016 TERMINATED D-1240-2016 TERMINATED D-1215-2016 TERMINATED D-1250-2016 TERMINATED D-1188-2016 TERMINATED D-1209-2016 TERMINATED D-1190-2016 TERMINATED D-1214-2016 TERMINATED D-1191-2016 TERMINATED D-1252-2016 TERMINATED D-1202-2016 TERMINATED D-1173-2016 TERMINATED D-1183-2016 TERMINATED D-1176-2016 TERMINATED D-1167-2016 TERMINATED D-1175-2016 TERMINATED D-1177-2016 TERMINATED D-1238-2016 TERMINATED D-1192-2016 TERMINATED D-1206-2016 TERMINATED D-1200-2016 TERMINATED D-1220-2016 TERMINATED D-1222-2016 TERMINATED D-1247-2016 TERMINATED D-1169-2016 TERMINATED D-1228-2016 TERMINATED D-1237-2016 TERMINATED D-1251-2016 TERMINATED D-1194-2016 TERMINATED D-1180-2016 TERMINATED D-1201-2016 TERMINATED D-1179-2016 TERMINATED D-1242-2016 TERMINATED D-1174-2016 TERMINATED D-1233-2016 TERMINATED D-1189-2016 TERMINATED D-1241-2016 TERMINATED D-1205-2016 TERMINATED D-1210-2016 TERMINATED D-1232-2016 TERMINATED D-1229-2016 TERMINATED D-1212-2016 TERMINATED D-1249-2016 TERMINATED D-1225-2016 TERMINATED D-1196-2016 TERMINATED D-1207-2016 TERMINATED D-1186-2106 TERMINATED D-1187-2016 TERMINATED D-1185-2016 TERMINATED D-1239-2016 TERMINATED D-1226-2016 TERMINATED D-1170-2016 TERMINATED D-1235-2016 TERMINATED D-1243-2016 TERMINATED D-1197-2016 TERMINATED D-1213-2016 TERMINATED D-1198-2016 TERMINATED D-1224-2016 TERMINATED D-1217-2016 TERMINATED D-1253-2016 TERMINATED D-1195-2106 TERMINATED D-1208-2016 TERMINATED D-1199-2016 TERMINATED D-1227-2016 TERMINATED D-1181-2016 TERMINATED D-1254-2016 TERMINATED D-1230-2016 TERMINATED D-1236-2016 TERMINATED D-1234-2016 TERMINATED D-1216-2016 TERMINATED D-1245-2016 TERMINATED D-1219-2016 TERMINATED D-1204-2016 TERMINATED D-1223-2016 TERMINATED D-1244-2016 TERMINATED D-1178-2016 TERMINATED D-1248-2016 TERMINATED D-1182-2016 TERMINATED D-1193-2016 TERMINATED D-1218-2016 TERMINATED D-1221-2016 TERMINATED D-1246-2016 TERMINATED D-1168-2016 TERMINATED D-1211-216 TERMINATED

Recall Number: D-1172-2016

Reason for Recall
Lack of Assurance of Sterility
Initiated
05-13-2016
Reported
07-20-2016
Quantity
1000 mL in Vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
74466
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.
Medaus, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S. Nationwide, Japan, and New Zealand.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-16-2017
Product Description About Product Description
Full technical description of the product.
B-COMPLEX 50 IN NACL 0.9% (PF) B1-50MG, B2-5-PO4-5MG, B3-50MG, B5-50MG, B6-50MG/ML, 2ML Vials, MEDAUS PHARMACY

Batch or Lot Expiration Information

Lot# : 160218-57, BUD: 08/16/16

Recall Number: D-1171-2016

Reason for Recall
Lack of Assurance of Sterility
Initiated
05-13-2016
Reported
07-20-2016
Quantity
955 mL in Vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
74466
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.
Medaus, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S. Nationwide, Japan, and New Zealand.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-16-2017
Product Description About Product Description
Full technical description of the product.
B-COMPLEX WITHOUT B12 W/PRES (BENZYL ETOH 2%), B1-100MG, B2-5-PO4-2MG, B3-50MG, B5-2MG, B6-2MG/ML, In a) 5ML Vials and b) 10ML Vials, MEDAUS PHARMACY

Batch or Lot Expiration Information

Lot# a)
Lot# : 151222-11, BUD: 05/28/16
Lot# : 151224-5, BUD: 05/28/16
Lot# : 160111-1, BUD: 05/28/16
Lot# : 160119-3, BUD: 05/28/16
Lot# : 160119-64, BUD: 05/28/16
Lot# : 160217-10, BUD: 05/28/16
Lot# : 160307-22, BUD: 05/28/16. b)
Lot# : 151223-30, BUD: 05/28/16
Lot# : 151224-2, BUD: 05/28/16
Lot# : 160111-1, BUD: 05/28/16
Lot# : 160112-2, BUD: 05/28/16
Lot# : 160118-2, BUD: 05/28/16
Lot# : 160119-64, BUD: 05/28/16
Lot# : 160125-1, BUD: 05/28/16
Lot# : 160208-4, BUD: 05/28/16
Lot# : 160210-64, BUD: 05/28/16
Lot# : 160215-6, BUD: 05/28/16
Lot# : 160222-14, BUD: 05/28/16
Lot# : 160307-22, BUD: 05/28/16
Lot# : 160307-23, BUD: 06/11/16.

Recall Number: D-1231-2016

Reason for Recall
Lack of Assurance of Sterility
Initiated
05-13-2016
Reported
07-20-2016
Quantity
104 mL in Vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
74466
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.
Medaus, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S. Nationwide, Japan, and New Zealand.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-16-2017
Product Description About Product Description
Full technical description of the product.
NIACINAMIDE 100 MG/ML (PF), In a) 1ML Vials, b) 5ML Vials, and c) 10ML Vials, MEDAUS PHARMACY

Batch or Lot Expiration Information

Lot# a)
Lot# : 160204-29, BUD: 08/02/16. b)
Lot# : 151123-73, BUD: 05/21/16
Lot# : 151124-42, BUD: 05/22/16
Lot# : 151201-20, BUD: 05/29/16
Lot# : 151215-10, BUD: 06/12/16
Lot# : 160229-46, BUD: 07/17/16
Lot# : 160202-33, BUD: 07/31/16. c)
Lot# : 160315-9, BUD: 09/11/16.

Recall Number: D-1203-2016

Reason for Recall
Lack of Assurance of Sterility
Initiated
05-13-2016
Reported
07-20-2016
Quantity
1000 mL in Vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
74466
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.
Medaus, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S. Nationwide, Japan, and New Zealand.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-16-2017
Product Description About Product Description
Full technical description of the product.
LIPO-INJECTION W/LIDOCAINE (PF), ASCORBIC ACID 50MG; B1-50MG; B2-5-PO4-5MG; B3-50MG B5-5MG, B6-5MG, CYANO B-12-100MCG, METHIONINE 12.5 MG, INOSITOL 25 MG, CHOLINE CL-25 MG, LIDCAINE 10 MG/ML, 2ML Vials, MEDAUS PHARMACY

Batch or Lot Expiration Information

Lot# : 151130-85, BUD: 05/26/16

Recall Number: D-1184-2016

Reason for Recall
Lack of Assurance of Sterility
Initiated
05-13-2016
Reported
07-20-2016
Quantity
250 mL in Vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
74466
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.
Medaus, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S. Nationwide, Japan, and New Zealand.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-16-2017
Product Description About Product Description
Full technical description of the product.
FOLIC ACID 10MG/ML IN NACL (PF), 1ML Vials, MEDAUS PHARMACY

Batch or Lot Expiration Information

Lot# : 151214-62, BUD: 06/11/16

Recall Number: D-1240-2016

Reason for Recall
Lack of Assurance of Sterility
Initiated
05-13-2016
Reported
07-20-2016
Quantity
10 mL in Vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
74466
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.
Medaus, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S. Nationwide, Japan, and New Zealand.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-16-2017
Product Description About Product Description
Full technical description of the product.
TAURINE 50 MG/ML W/PRES. (BENZALKONIUM CHL 0.01%), 10ML Vials, MEDAUS PHARMACY

Batch or Lot Expiration Information

Lot# : 160315-4, BUD: 05/30/16

Recall Number: D-1215-2016

Reason for Recall
Lack of Assurance of Sterility
Initiated
05-13-2016
Reported
07-20-2016
Quantity
20 mL in Vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
74466
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.
Medaus, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S. Nationwide, Japan, and New Zealand.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-16-2017
Product Description About Product Description
Full technical description of the product.
METHYL B12 1000MCG/ML/PYRIDOXINE 100MG W/PRES. (BENZALKONIUM 0.01%), In a) 1ML Vials and b) 10ML Vials, MEDAUS PHARMACY

Batch or Lot Expiration Information

Lot# a)
Lot# : 160222-85, BUD: 07/05/16. b)
Lot# : 160222-85, BUD: 07/05/16.

Recall Number: D-1250-2016

Reason for Recall
Lack of Assurance of Sterility
Initiated
05-13-2016
Reported
07-20-2016
Quantity
500 mL in Vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
74466
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.
Medaus, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S. Nationwide, Japan, and New Zealand.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-16-2017
Product Description About Product Description
Full technical description of the product.
ZINC CHLORIDE 10MG/ML IN NACL 0.29% (PF), 2ML Vials, MEDAUS PHARMACY

Batch or Lot Expiration Information

Lot# : 160120-57, BUD: 07/18/16

Recall Number: D-1188-2016

Reason for Recall
Lack of Assurance of Sterility
Initiated
05-13-2016
Reported
07-20-2016
Quantity
500 mL in Vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
74466
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.
Medaus, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S. Nationwide, Japan, and New Zealand.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-16-2017
Product Description About Product Description
Full technical description of the product.
HYALURONIDASE 500U/ML(PF), 3ML Vials, MEDAUS PHARMACY

Batch or Lot Expiration Information

Lot# : 151230-23, BUD: 06/27/16

Recall Number: D-1209-2016

Reason for Recall
Lack of Assurance of Sterility
Initiated
05-13-2016
Reported
07-20-2016
Quantity
4000 mL in Vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
74466
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.
Medaus, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S. Nationwide, Japan, and New Zealand.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-16-2017
Product Description About Product Description
Full technical description of the product.
LIPO-INJECTION W/LIDOCAINE NO METHIONINE W/PRES. (BENZYL ETOH 2%) ASCORBIC ACID-50MG, B1-50MG, B2-5 PO4-5MG, B-3-50MG, B5-5MG, B6-5MG, CYANO B12-100MCG,INOSITOL 25MG, CHOLINE CHL-25MG, LIDOCAINE-10MG/ML, 5ML Vials, MEDAUS PHARMACY

Batch or Lot Expiration Information

Lot# : 151210-46, BUD: 06/07/16
Lot# : 160208-50, BUD: 07/31/16

Recall Number: D-1190-2016

Reason for Recall
Lack of Assurance of Sterility
Initiated
05-13-2016
Reported
07-20-2016
Quantity
210 mL in Vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
74466
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.
Medaus, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S. Nationwide, Japan, and New Zealand.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-16-2017
Product Description About Product Description
Full technical description of the product.
HYDROXY B12 5MG/ML W/PRES (BENZALKONIUM 0.01%), 5ML Vials, MEDAUS PHARMACY

Batch or Lot Expiration Information

Lot# : 160202-12, BUD: 07/11/16
Lot# : 160204-10, BUD: 07/11/16
Lot# : 160210-70, BUD: 07/11/16
Lot# : 160215-11, BUD: 07/11/16
Lot# : 160222-17, BUD: 07/11/16
Lot# : 160223-64, BUD: 07/11/16
Lot# : 160224-67, BUD: 07/11/16
Lot# : 160307-28, BUD: 07/11/16
Lot# : 160308-1, BUD: 07/11/16
Lot# : 160309-3, BUD: 07/11/16

Recall Number: D-1214-2016

Reason for Recall
Lack of Assurance of Sterility
Initiated
05-13-2016
Reported
07-20-2016
Quantity
8020 mL in Vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
74466
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.
Medaus, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S. Nationwide, Japan, and New Zealand.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-16-2017
Product Description About Product Description
Full technical description of the product.
METHYL B12 1000MCG/ML W/PRES (BENZALKONIUM 0.01% IN NACL 0.9%, In a) 2ML Vials, b) 5ML Vials, and c) 10ML Vials, MEDAUS PHARMACY

Batch or Lot Expiration Information

Lot# a)
Lot# : 151218-30, BUD: 06/15/16
Lot# : 151221-70, BUD: 06/18/16. b)
Lot# : 151221-78, BUD: 06/18/16
Lot# : 160217-40, BUD: 08/15/16. c)
Lot# : 151221-78, BUD: 06/18/16
Lot# : 160217-40, BUD: 08/15/16.

Recall Number: D-1191-2016

Reason for Recall
Lack of Assurance of Sterility
Initiated
05-13-2016
Reported
07-20-2016
Quantity
800 mL in Vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
74466
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.
Medaus, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S. Nationwide, Japan, and New Zealand.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-16-2017
Product Description About Product Description
Full technical description of the product.
HYDROXY B12 5MG/ML IN NACL 0.9% (PF), In a) 1ML Vials and b) 2ML Vials, MEDAUS PHARMACY

Batch or Lot Expiration Information

Lot# a)
Lot# : 160119-8, BUD: 07/17/16
Lot# : 160204-30, BUD: 08/02/16. b)
Lot# : 160119-8, BUD: 07/17/16
Lot# : 160204-30, BUD: 08/02/16.

Recall Number: D-1252-2016

Reason for Recall
Lack of Assurance of Sterility
Initiated
05-13-2016
Reported
07-20-2016
Quantity
1000 mL in Vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
74466
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.
Medaus, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S. Nationwide, Japan, and New Zealand.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-16-2017
Product Description About Product Description
Full technical description of the product.
ARGININE 100MG/ML (PF), 10ML Vials, MEDAUS PHARMACY

Batch or Lot Expiration Information

Lot# : 151217-12, BUD: 06/14/16

Recall Number: D-1202-2016

Reason for Recall
Lack of Assurance of Sterility
Initiated
05-13-2016
Reported
07-20-2016
Quantity
1000 mL in Vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
74466
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.
Medaus, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S. Nationwide, Japan, and New Zealand.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-16-2017
Product Description About Product Description
Full technical description of the product.
LIPO #4 W/METHYL B12 500 MCG/ML/NO METHIONINE W/PRES (BENZYL ETOH 2%) ASCORBIC ACID 50MG; B1-50MG;B2-5-P04-5MG;B3-30MG; B5-5MG;B6-5MG;METHYL B12 500 MCG; LIDOCAINE 10 MG; INOSITOL-25MG; CHOLINE CHL-25 MG/ML; 5ML Vials, MEDAUS PHARMACY

Batch or Lot Expiration Information

Lot# : 160203-2, BUD: 07/31/16

Recall Number: D-1173-2016

Reason for Recall
Lack of Assurance of Sterility
Initiated
05-13-2016
Reported
07-20-2016
Quantity
4000 mL in Vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
74466
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.
Medaus, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S. Nationwide, Japan, and New Zealand.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-16-2017
Product Description About Product Description
Full technical description of the product.
B-COMPLEX 50 IN NACL 0.9% W/PRES., (BENZYL ETOH 2%), B1-50MG, B2-5-PO4-5MG, B3-50MG, B5-50MG, B6-50MG/ML, 10ML Vials, MEDAUS PHARMACY

Batch or Lot Expiration Information

Lot# : 151220-4, BUD: 06/17/16
Lot# : 160216-31, BUD: 08/14/16

Recall Number: D-1183-2016

Reason for Recall
Lack of Assurance of Sterility
Initiated
05-13-2016
Reported
07-20-2016
Quantity
10 mL in Vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
74466
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.
Medaus, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S. Nationwide, Japan, and New Zealand.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-16-2017
Product Description About Product Description
Full technical description of the product.
ESTRADIOLVAL 3MG/TEST CYP 35MG/ TEST PROP 35MG/ML W/PRES. (BENZYL ETOH 2%), 3ML Vials, MEDAUS PHARMACY

Batch or Lot Expiration Information

Lot# : 151218-14, BUD: 06/15/16

Recall Number: D-1176-2016

Reason for Recall
Lack of Assurance of Sterility
Initiated
05-13-2016
Reported
07-20-2016
Quantity
8500 mL in Vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
74466
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.
Medaus, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S. Nationwide, Japan, and New Zealand.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-16-2017
Product Description About Product Description
Full technical description of the product.
CALCIUM SODIUM EDTA 300MG/ML (PF), 10ML Vials, MEDAUS PHARMACY

Batch or Lot Expiration Information

Lot# : 151123-11, BUD: 05/21/16
Lot# : 160105-24, BUD: 07/03/16
Lot# : 160118-7, BUD: 07/16/16

Recall Number: D-1167-2016

Reason for Recall
Lack of Assurance of Sterility
Initiated
05-13-2016
Reported
07-20-2016
Quantity
1000 mL in Vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
74466
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.
Medaus, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S. Nationwide, Japan, and New Zealand.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-16-2017
Product Description About Product Description
Full technical description of the product.
B-COMPLEX #3 (PF), B1-100MG, B2-2-PO4-2MG, B3-100MG, B5-2MG, B6-2MG/ML, 2ML Vials, MEDAUS PHARMACY

Batch or Lot Expiration Information

Lot# : 151228-28, BUD: 06/25/16

Recall Number: D-1175-2016

Reason for Recall
Lack of Assurance of Sterility
Initiated
05-13-2016
Reported
07-20-2016
Quantity
370 mL in Vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
74466
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.
Medaus, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S. Nationwide, Japan, and New Zealand.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-16-2017
Product Description About Product Description
Full technical description of the product.
B-COMPLEX W/METHYL B12/LIDO W/PRES (BENZYL ETOH 2%), B1-100MG, B2-5-PO4-2MG, B3-50MG, B5-2MG, B6-2MG, LIDOCAINE 1%, METHYL B12 1MG/ML, In a) 1ML Vials, b) 5ML Vials, and c) 10ML Vials, MEDAUS PHARMACY

Batch or Lot Expiration Information

Lot# a)
Lot# : 151228-62, BUD: 06/25/16. b)
Lot# : 160111-2, BUD: 06/11/16
Lot# : 160113-3, BUD: 06/11/16
Lot# : 160113-76, BUD: 06/11/16
Lot# : 160118-1, BUD: 06/11/16
Lot# : 160119-2, BUD: 06/11/16
Lot# : 160119-65, BUD: 06/11/16
Lot# : 160122-9, BUD: 06/11/16
Lot# : 160128-10, BUD: 06/11/16
Lot# : 160202-65, BUD: 06/11/16
Lot# : 160204-44, BUD: 06/11/16
Lot# : 160217-54, BUD: 06/11/16
Lot# : 160223-5, BUD: 06/11/16
Lot# : 160224-66, BUD: 06/11/16
Lot# : 160229-23, BUD: 06/11/16
Lot# : 160315-3, BUD: 06/11/16. c)
Lot# : 160118-1, BUD: 06/11/16
Lot# : 160127-2, BUD: 06/11/16
Lot# : 160210-37, BUD: 06/11/16
Lot# : 160223-5, BUD: 06/11/16
Lot# : 160310-14, BUD: 06/11/16.

Recall Number: D-1177-2016

Reason for Recall
Lack of Assurance of Sterility
Initiated
05-13-2016
Reported
07-20-2016
Quantity
506 mL in Vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
74466
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.
Medaus, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S. Nationwide, Japan, and New Zealand.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-16-2017
Product Description About Product Description
Full technical description of the product.
CESIUM CHLORIDE 600MG/ML (PF), 10ML Vials, MEDAUS PHARMACY

Batch or Lot Expiration Information

Lot# : 151207-10, BUD: 06/04/16
Lot# : 151222-18, BUD: 06/19/16
Lot# : 151222-20, BUD: 06/19/16
Lot# : 160210-47, BUD: 08/29/16
Lot# : 160210-49, BUD: 08/29/16
Lot# : 160215-20, BUD: 08/13/16
Lot# : 160302-45, BUD: 08/29/16
Lot# : 160302-56, BUD: 08/29/16

Recall Number: D-1238-2016

Reason for Recall
Lack of Assurance of Sterility
Initiated
05-13-2016
Reported
07-20-2016
Quantity
884 mL in Vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
74466
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.
Medaus, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S. Nationwide, Japan, and New Zealand.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-16-2017
Product Description About Product Description
Full technical description of the product.
SELENIUM 200MCG/ML (PF), 10ML Vials, MEDAUS PHARMACY

Batch or Lot Expiration Information

Lot# : 151130-35, BUD: 05/21/16
Lot# : 151202-28, BUD: 05/21/16
Lot# : 151223-68, BUD: 05/21/16
Lot# : 151216-20, BUD: 05/21/16
Lot# : 151123-77, BUD: 05/21/16
Lot# : 151204-22, BUD: 05/21/16
Lot# : 160111-30, BUD: 05/21/16
Lot# : 160112-27, BUD: 05/21/16
Lot# : 160120-8, BUD: 05/21/16
Lot# : 160118-12, BUD: 05/21/16
Lot# : 160119-20, BUD: 05/21/16
Lot# : 160202-37, BUD: 05/21/16
Lot# : 160208-61, BUD: 05/21/16
Lot# : 160208-62, BUD: 05/21/16
Lot# : 160216-37, BUD: 08/14/16
Lot# : 160216-38, BUD: 08/14/16
Lot# : 160216-35, BUD: 08/14/16
Lot# : 160216-40, BUD: 08/14/16
Lot# : 160223-27, BUD: 08/14/16
Lot# : 160229-43, BUD: 08/14/16
Lot# : 160303-22, BUD: 08/14/16
Lot# : 160309-17, BUD: 08/14/16

Recall Number: D-1192-2016

Reason for Recall
Lack of Assurance of Sterility
Initiated
05-13-2016
Reported
07-20-2016
Quantity
7000 mL in Vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
74466
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.
Medaus, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S. Nationwide, Japan, and New Zealand.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-16-2017
Product Description About Product Description
Full technical description of the product.
HYDROXY B12 1000MCG/ML W/PRES (BENZALKONIUM 0.01%), 10ML Vials, MEDAUS PHARMACY

Batch or Lot Expiration Information

Lot# : 151221-56, BUD: 06/18/16
Lot# : 160203-23, BUD: 08/01/16
Lot# : 160218-45, BUD: 08/16/16

Recall Number: D-1206-2016

Reason for Recall
Lack of Assurance of Sterility
Initiated
05-13-2016
Reported
07-20-2016
Quantity
2000 mL in Vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
74466
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.
Medaus, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S. Nationwide, Japan, and New Zealand.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-16-2017
Product Description About Product Description
Full technical description of the product.
LIPO-INJECTION W/METHYL B12 1 MG/ML W/PRES. (BENZYL ETOH 2%) ASCORBIC ACID-50MG, B1-50MG, B2-5 PHOS-5MG, B-3-50MG, B5-5MG, B6-5MG, METHYL B12-1MG, LIDOCAINE-10MG, METHIONINE 12.5 MG, INOSITOL 25MG, CHOLINE CHL 25MG/ML, In a) 5ML Vials and b) 10ML Vials, MEDAUS PHARMACY

Batch or Lot Expiration Information

Lot# a)
Lot# : 160208-41, BUD: 07/31/16. b)
Lot# : 160208-41, BUD: 07/31/16.

Recall Number: D-1200-2016

Reason for Recall
Lack of Assurance of Sterility
Initiated
05-13-2016
Reported
07-20-2016
Quantity
147 mL in Vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
74466
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.
Medaus, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S. Nationwide, Japan, and New Zealand.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-16-2017
Product Description About Product Description
Full technical description of the product.
LIDOCAINE 2% (PF) IN NACL, 10ML Vials, MEDAUS PHARMACY

Batch or Lot Expiration Information

Lot# : 151203-48, BUD: 05/31/16
Lot# : 151204-9, BUD: 06/01/16
Lot# : 151218-20, BUD: 06/15/16
Lot# : 160125-23, BUD: 07/23/16
Lot# : 160125-24, BUD: 07/23/16
Lot# : 160125-25, BUD: 07/23/16
Lot# : 160127-6, BUD: 07/25/16
Lot# : 160302-76, BUD: 08/29/16
Lot# : 160302-77, BUD: 08/29/16

Recall Number: D-1220-2016

Reason for Recall
Lack of Assurance of Sterility
Initiated
05-13-2016
Reported
07-20-2016
Quantity
187 mL in Vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
74466
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.
Medaus, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S. Nationwide, Japan, and New Zealand.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-16-2017
Product Description About Product Description
Full technical description of the product.
M.I.C. 25/50/50 (PF) METHIONINE 25MG;INOSITOL 50MG;CHOLINE CHL 50MG/ML, In 2ML Vials, MEDAUS PHARMACY

Batch or Lot Expiration Information

Lot# : 151130-48, BUD: 05/26/16
Lot# : 151215-7, BUD: 05/26/16
Lot# : 151216-12, BUD: 05/26/16
Lot# : 160106-27, BUD: 05/26/16
Lot# : 160113-38, BUD: 07/11/16
Lot# : 160223-33, BUD: 07/31/16
Lot# : 160307-36, BUD: 07/31/16
Lot# : 160307-52, BUD: 07/31/16
Lot# : 160308-5, BUD: 07/31/16

Recall Number: D-1222-2016

Reason for Recall
Lack of Assurance of Sterility
Initiated
05-13-2016
Reported
07-20-2016
Quantity
110 mL in Vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
74466
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.
Medaus, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S. Nationwide, Japan, and New Zealand.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-16-2017
Product Description About Product Description
Full technical description of the product.
M.I.C B-COMPLEX PREMIX W/HYDROXY B12 W/PRES. (BENZALKONIUM 0.01%) HYDROXY B12 1MG; B1 0.833MG; B2 0.083MG; B3 0.833MG, B5 0.083MG, B6 0.083MG, CYANO B12 1.66MCG, METHIONINE 0.208MG, INOSITOL 0.416MG, CHOLINE CL 1.66MG/ML, 10ML Vials, MEDAUS PHARMACY

Batch or Lot Expiration Information

Lot# : 160229-24, BUD: 07/25/16
Lot# : 160315-5, BUD: 07/25/16

Recall Number: D-1247-2016

Reason for Recall
Lack of Assurance of Sterility
Initiated
05-13-2016
Reported
07-20-2016
Quantity
213 mL in Vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
74466
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.
Medaus, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S. Nationwide, Japan, and New Zealand.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-16-2017
Product Description About Product Description
Full technical description of the product.
THIAMINE 100 MG/ML W/PRES (BENZALKONIUM 0.01%), 5ML Vials, MEDAUS PHARMACY

Batch or Lot Expiration Information

Lot# : 160129-2, BUD: 06/07/16
Lot# : 160201-10, BUD: 06/07/16
Lot# : 160222-19, BUD: 06/07/16
Lot# : 160215-12, BUD: 06/07/16
Lot# : 160315-2, BUD: 06/07/16

Recall Number: D-1169-2016

Reason for Recall
Lack of Assurance of Sterility
Initiated
05-13-2016
Reported
07-20-2016
Quantity
60 mL in Vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
74466
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.
Medaus, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S. Nationwide, Japan, and New Zealand.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-16-2017
Product Description About Product Description
Full technical description of the product.
B-COMPLEX (LIEBERMAN) IN NACL 0.9% (PF), B1-12.5MG, B2-5-PO4-10MG, B3-12.5MG, B5-12.5MG, B6-12.5MG/ML, 2ML Vials, MEDAUS PHARMACY

Batch or Lot Expiration Information

Lot# : 151229-15, BUD: 06/26/16

Recall Number: D-1228-2016

Reason for Recall
Lack of Assurance of Sterility
Initiated
05-13-2016
Reported
07-20-2016
Quantity
157,500 mL in Vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
74466
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.
Medaus, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S. Nationwide, Japan, and New Zealand.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-16-2017
Product Description About Product Description
Full technical description of the product.
NA ASCORBATE 500MG/ML (PF), In a) 10ML Vials, b) 50ML Vials, and c) 100ML Vials, MEDAUS PHARMACY

Batch or Lot Expiration Information

Lot# a)
Lot# : 151217-47, BUD: 06/14/16
Lot# : 160112-51, BUD: 07/10/16
Lot# : 160127-43, BUD: 07/25/16
Lot# : 160218-8, BUD: 08/16/16
Lot# : 151211-26, BUD: 06/08/16. b)
Lot# : 151211-26, BUD: 06/08/16
Lot# : 151217-47, BUD: 06/14/16
Lot# : 160112-51, BUD: 07/10/16
Lot# : 160127-43, BUD: 07/25/16
Lot# : 160218-8, BUD: 08/16/16. c)
Lot# : 151211-26, BUD: 06/08/16
Lot# : 160112-51, BUD: 07/10/16
Lot# : 160127-43, BUD: 07/25/16
Lot# : 151217-47, BUD: 06/14/16
Lot# : 160218-8, BUD: 08/16/16.

Recall Number: D-1237-2016

Reason for Recall
Lack of Assurance of Sterility
Initiated
05-13-2016
Reported
07-20-2016
Quantity
35 mL in Vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
74466
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.
Medaus, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S. Nationwide, Japan, and New Zealand.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-16-2017
Product Description About Product Description
Full technical description of the product.
RIBOFLAVIN 10MG/ML (PF), In a) 1ML Vials and b) 2ML Vials, MEDAUS PHARMACY

Batch or Lot Expiration Information

Lot# a)
Lot# : 151123-74, BUD: 05/21/16
Lot# : 160315-10, BUD: 09/11/16. b)
Lot# : 160204-21, BUD: 08/02/16.

Recall Number: D-1251-2016

Reason for Recall
Lack of Assurance of Sterility
Initiated
05-13-2016
Reported
07-20-2016
Quantity
2000 mL in Vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
74466
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.
Medaus, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S. Nationwide, Japan, and New Zealand.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-16-2017
Product Description About Product Description
Full technical description of the product.
ZINC SO4 10MG/ML (PF), Vials 2ML, MEDAUS PHARMACY

Batch or Lot Expiration Information

Lot# : 151203-53; BUD: 05/31/16
Lot# : 151217-38; BUD: 06/14/16
Lot# : 160208-36; BUD: 08/06/16

Recall Number: D-1194-2016

Reason for Recall
Lack of Assurance of Sterility
Initiated
05-13-2016
Reported
07-20-2016
Quantity
1400 mL in Vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
74466
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.
Medaus, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S. Nationwide, Japan, and New Zealand.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-16-2017
Product Description About Product Description
Full technical description of the product.
L-CARNITINE 100MG/ML (PF), 10ML Vials, MEDAUS PHARMACY

Batch or Lot Expiration Information

Lot# : 151123-18, BUD: 05/21/16
Lot# : 151124-39, BUD: 05/22/16
Lot# : 160203-42, BUD: 08/01/16

Recall Number: D-1180-2016

Reason for Recall
Lack of Assurance of Sterility
Initiated
05-13-2016
Reported
07-20-2016
Quantity
1000 mL in Vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
74466
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.
Medaus, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S. Nationwide, Japan, and New Zealand.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-16-2017
Product Description About Product Description
Full technical description of the product.
DMPS 50MG/ML (PF), 5ML Vials, MEDAUS PHARMACY

Batch or Lot Expiration Information

Lot# : 151216-33, BUD: 06/13/16

Recall Number: D-1201-2016

Reason for Recall
Lack of Assurance of Sterility
Initiated
05-13-2016
Reported
07-20-2016
Quantity
7000 mL in Vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
74466
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.
Medaus, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S. Nationwide, Japan, and New Zealand.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-16-2017
Product Description About Product Description
Full technical description of the product.
LIPO W/LIDOCAINE #3 W/PRES. (BENZYL ETOH 2%) ASCORBIC ACID 50MG; B1-50MG;B2-5-P04-5MG;D3-30MG; B5-5MG;B6-5MG;CYANO B12-1MG; METHIONINE 12.5MG; INOSITOL-25MG; CHOLINE CL-25 MG; LIDOCAINE 10MG/ML, In a) 5 ML Vials and b) 10ML Vials, MEDAUS PHARMACY

Batch or Lot Expiration Information

Lot# a)
Lot# : 160107-37, BUD: 07/5/16
Lot# : 160303-67, BUD: 07/31/16. b)
Lot# : 160107-37, BUD: 07/5/16
Lot# : 160303-67, BUD: 07/31/16.

Recall Number: D-1179-2016

Reason for Recall
Lack of Assurance of Sterility
Initiated
05-13-2016
Reported
07-20-2016
Quantity
1110 mL in Vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
74466
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.
Medaus, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S. Nationwide, Japan, and New Zealand.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-16-2017
Product Description About Product Description
Full technical description of the product.
DEXPANTHENOL 250MG/ML W/PRES. (BENZALKONIUM CHL 0.01%), 10ML Vials, MEDAUS PHARMACY

Batch or Lot Expiration Information

Lot# : 160204-45, BUD: 06/14/16
Lot# : 160210-38, BUD: 06/14/16
Lot# : 160215-9, BUD: 06/14/16
Lot# : 160222-16, BUD: 06/14/16
Lot# : 160223-6, BUD: 06/14/16
Lot# : 160229-74, BUD: 06/14/16
Lot# : 160302-31, BUD: 06/14/16
Lot# : 160307-27, BUD: 06/14/16

Recall Number: D-1242-2016

Reason for Recall
Lack of Assurance of Sterility
Initiated
05-13-2016
Reported
07-20-2016
Quantity
8000 mL in Vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
74466
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.
Medaus, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S. Nationwide, Japan, and New Zealand.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-16-2017
Product Description About Product Description
Full technical description of the product.
TESTOSTERONE CYP 200 MG/ML W/PRES (BENZYL ETOH 2%), In a) 1ML Vials, b) 2ML Vials, c) 3ML Vials, d) 4ML, and e) 5ML Vials, MEDAUS PHARMACY

Batch or Lot Expiration Information

Lot# a)
Lot# 151210-5, BUD: 06/07/16
Lot# 160204-31, BUD: 08/02/16
Lot# 160107-8, BUD: 07/05/16
Lot# 160303-47, BUD: 08/30/16. b)
Lot# 151210-5, BUD: 06/07/16
Lot# 160107-8, BUD: 07/05/16
Lot# 160204-31, BUD: 08/02/16
Lot# 160303-47, BUD: 08/30/16. c)
Lot# 151207-8, BUD: 06/04/16
Lot# 160303-47, BUD: 08/30/16
Lot# 151210-5, BUD: 06/07/16
Lot# 160107-8, BUD: 07/05/16
Lot# 160204-31, BUD: 08/02/16
Lot# 160106-34, BUD: 07/04/16
Lot# 160208-22, BUD: 08/06/16. d)
Lot# 151210-5, BUD: 06/07/16
Lot# 160107-8, BUD: 07/05/16
Lot# 160204-31, BUD: 08/02/16
Lot# 160303-47, BUD: 08/30/16. e)
Lot# 151210-5, BUD: 06/07/16
Lot# 160107-8, BUD: 07/05/16
Lot# 160204-31, BUD: 08/02/16
Lot# 160303-47, BUD: 08/30/16.

Recall Number: D-1174-2016

Reason for Recall
Lack of Assurance of Sterility
Initiated
05-13-2016
Reported
07-20-2016
Quantity
62 mL in Vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
74466
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.
Medaus, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S. Nationwide, Japan, and New Zealand.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-16-2017
Product Description About Product Description
Full technical description of the product.
B-COMPLEX W/CYANO B12 W/PRES., (BENZYL ETOH 2%), B1-100MG, B2-5-PO4-2MG, B3-50MG, B5-2MG, B6-2MG, CYANO B12 1MG/ML, In a) 2ML Vials, b) 5MLVials, c) 10ML Vials, MEDAUS PHARMACY

Batch or Lot Expiration Information

Lot# a)
Lot# : 160209-24, BUD: 05/28/16. b)
Lot# : 160106-12, BUD: 05/28/16
Lot# : 160222-70, BUD: 05/28/16. c)
Lot# : 160129-9, BUD: 05/28/16
Lot# : 160202-16, BUD: 05/28/16.

Recall Number: D-1233-2016

Reason for Recall
Lack of Assurance of Sterility
Initiated
05-13-2016
Reported
07-20-2016
Quantity
60 mL in Vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
74466
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.
Medaus, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S. Nationwide, Japan, and New Zealand.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-16-2017
Product Description About Product Description
Full technical description of the product.
PROLINE 100MG/ML (PF), 5ML Vials, MEDAUS PHARMACY

Batch or Lot Expiration Information

Lot# : 160308-3, BUD: 09/04/16

Recall Number: D-1189-2016

Reason for Recall
Lack of Assurance of Sterility
Initiated
05-13-2016
Reported
07-20-2016
Quantity
1000 mL in Vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
74466
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.
Medaus, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S. Nationwide, Japan, and New Zealand.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-16-2017
Product Description About Product Description
Full technical description of the product.
HYDROGEN PEROXIDE 3% (PF), 5ML Vials, MEDAUS PHARMACY

Batch or Lot Expiration Information

Lot# : 160112-35, BUD: 07/10/16

Recall Number: D-1241-2016

Reason for Recall
Lack of Assurance of Sterility
Initiated
05-13-2016
Reported
07-20-2016
Quantity
500 mL in Vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
74466
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.
Medaus, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S. Nationwide, Japan, and New Zealand.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-16-2017
Product Description About Product Description
Full technical description of the product.
TESTOSTERONE CYP 100 MG/ML W/PRES (BENZYL ETOH 2%), In a) 1ML Vials, b) 2ML Vials, c) 3ML Vials, and d) 5 ML Vials, MEDAUS PHARMACY

Batch or Lot Expiration Information

Lot# a)
Lot# : 160115-17, BUD: 07/13/16. b)
Lot# : 160115-17, BUD: 07/13/16. c)
Lot# : 160115-17, BUD: 07/13/16. d)
Lot# : 160115-17, BUD: 07/13/16.

Recall Number: D-1205-2016

Reason for Recall
Lack of Assurance of Sterility
Initiated
05-13-2016
Reported
07-20-2016
Quantity
65 mL in Vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
74466
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.
Medaus, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S. Nationwide, Japan, and New Zealand.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-16-2017
Product Description About Product Description
Full technical description of the product.
LIPO-BOOST W/PRES. (BENZYL ETOH 2%) B1-50MG, B2-5-PO4-2MG, B3-100MG, B5-2MG, B6-52MG, METHYL, B12-500MCG, CARNITINE 50 MG, METHIONINE 12.5MG, INOSITOL 25MG, CHOLINE CHL-25MG, LIDOCAINE 30MG/ML, In a) 3ML Vials and b) 5ML Vials, MEDAUS PHARMACY

Batch or Lot Expiration Information

Lot# a)
Lot# : 160209-36, BUD: 07/31/16. b)
Lot# : 151202-20, BUD: 05/26/16
Lot# : 151214-49, BUD: 05/26/16.

Recall Number: D-1210-2016

Reason for Recall
Lack of Assurance of Sterility
Initiated
05-13-2016
Reported
07-20-2016
Quantity
14000 mL in Vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
74466
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.
Medaus, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S. Nationwide, Japan, and New Zealand.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-16-2017
Product Description About Product Description
Full technical description of the product.
LIPO-INJECTION W/LIDOCAINE W/PRES. (BENZYL ETOH 2%) ASCORBIC ACID-50MG, B1-50MG, B2-5 PO4-5MG, B-3-50MG, B5-5MG, B6-5MG, CYANO B12-100MCG, METHIONINE 12.5MG, INOSITOL 25MG, CHOLINE CHL-25MG, LIDOCAINE-10MG/ML, In a) 5ML Vials and b) 10ML Vials, MEDAUS PHARMACY

Batch or Lot Expiration Information

Lot# a)
Lot# : 160104-40, BUD: 05/26/16
Lot# : 160209-28, BUD: 07/31/16. b)
Lot# : 160104-40, BUD: 05/26/16
Lot# : 160209-28, BUD: 07/31/16.

Recall Number: D-1232-2016

Reason for Recall
Lack of Assurance of Sterility
Initiated
05-13-2016
Reported
07-20-2016
Quantity
1500 mL in Vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
74466
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.
Medaus, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S. Nationwide, Japan, and New Zealand.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-16-2017
Product Description About Product Description
Full technical description of the product.
PROCAINE 2% (PF), In a) 2ML Vials and b) 10ML Vials, MEDAUS PHARMACY

Batch or Lot Expiration Information

Lot# a)
Lot# : 160112-47, BUD: 07/10/16
Lot# : 160225-9, BUD: 08/23/16. b)
Lot# : 160112-47, BUD: 07/10/16
Lot# : 160225-9, BUD: 08/23/16.

Recall Number: D-1229-2016

Reason for Recall
Lack of Assurance of Sterility
Initiated
05-13-2016
Reported
07-20-2016
Quantity
358000 mL in Vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
74466
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.
Medaus, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S. Nationwide, Japan, and New Zealand.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-16-2017
Product Description About Product Description
Full technical description of the product.
NA ASCORBATE 500MG/ML NON-CORN (PF), In a) 10ML Vials, b) 50ML Vials, and c) 100ML Vials, MEDAUS PHARMACY

Batch or Lot Expiration Information

Lot# a)
Lot# : 151201-30, BUD: 05/29/16
Lot# : 151209-26, BUD: 06/06/16
Lot# : 151216-63, BUD: 06/13/16
Lot# : 151231-11, BUD: 06/28/16
Lot# : 160105-4, BUD: 07/03/16
Lot# : 160125-41, BUD: 07/23/16
Lot# : 160211-20, BUD: 08/09/16. b)
Lot# : 151201-30, BUD: 05/29/16
Lot# : 151209-26, BUD: 06/06/16
Lot# : 151216-63, BUD: 06/13/16
Lot# : 151231-11, BUD: 06/28/16
Lot# : 160105-4, BUD: 07/03/16
Lot# : 160125-41, BUD: 07/23/16
Lot# : 160511-20, BUD: 08/09/16. c)
Lot# : 151201-30, BUD: 05/29/16
Lot# : 151209-26, BUD: 06/06/16
Lot# : 151216-63, BUD: 06/13/16
Lot# : 151231-11, BUD: 06/28/16
Lot# : 160105-4, BUD: 07/03/16
Lot# : 160125-41, BUD: 07/23/16
Lot# : 160511-20, BUD: 08/09/16.

Recall Number: D-1212-2016

Reason for Recall
Lack of Assurance of Sterility
Initiated
05-13-2016
Reported
07-20-2016
Quantity
1000 mL in Vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
74466
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.
Medaus, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S. Nationwide, Japan, and New Zealand.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-16-2017
Product Description About Product Description
Full technical description of the product.
MANGANESE CHL 0.1MG/ML PF, 10ML Vials, MEDAUS PHARMACY

Batch or Lot Expiration Information

Lot# : 151214-64, BUD: 5/31/16

Recall Number: D-1249-2016

Reason for Recall
Lack of Assurance of Sterility
Initiated
05-13-2016
Reported
07-20-2016
Quantity
2000 mL in Vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
74466
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.
Medaus, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S. Nationwide, Japan, and New Zealand.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-16-2017
Product Description About Product Description
Full technical description of the product.
TRYPTOPHAN 10MG/ML (PF), In a) 10ML Vials and b) 50ML Vials, MEDAUS PHARMACY

Batch or Lot Expiration Information

Lot# a)
Lot# : 160125-14, BUD: 07/23/16
Lot# : 160315-12, BUD: 09/11/16. b)
Lot# : 160125-14, BUD: 07/23/16
Lot# : 160315-12, BUD: 09/11/16.

Recall Number: D-1225-2016

Reason for Recall
Lack of Assurance of Sterility
Initiated
05-13-2016
Reported
07-20-2016
Quantity
2000 mL in Vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
74466
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.
Medaus, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S. Nationwide, Japan, and New Zealand.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-16-2017
Product Description About Product Description
Full technical description of the product.
M.I.C 25/50/50 W/METHYL B12 1MG/PYRIDOXAL 50MG/ML (PF), 1ML Vials, MEDAUS PHARMACY

Batch or Lot Expiration Information

Lot# : 151223-63, BUD: 05/26/16

Recall Number: D-1196-2016

Reason for Recall
Lack of Assurance of Sterility
Initiated
05-13-2016
Reported
07-20-2016
Quantity
2250 mL in Vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
74466
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.
Medaus, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S. Nationwide, Japan, and New Zealand.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-16-2017
Product Description About Product Description
Full technical description of the product.
L-CARNITINE 250MG/ML (PF), 10ML Vials, MEDAUS PHARMACY

Batch or Lot Expiration Information

Lot# : 151123-72, BUD: 05/21/16
Lot# : 151124-33, BUD: 05/22/16
Lot# : 151217-18, BUD: 06/14/16
Lot# : 151217-22, BUD: 06/14/16
Lot# : 151221-3, BUD: 06/18/16
Lot# : 160303-64, BUD: 08/30/16

Recall Number: D-1207-2016

Reason for Recall
Lack of Assurance of Sterility
Initiated
05-13-2016
Reported
07-20-2016
Quantity
4000 mL in Vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
74466
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.
Medaus, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S. Nationwide, Japan, and New Zealand.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-16-2017
Product Description About Product Description
Full technical description of the product.
LIPO-INJECTION W/METHYL B12 500 MCG/ML W/PRES. (BENZYL ETOH 2%) ASCORBIC ACID-50MG, B1-50MG, B2-5 PHOS-5MG, B-3-50MG, B5-5MG, B6-5MG, METHYL B12-500MCG, LIDOCAINE-10MG, METHIONINE 12.5 MG, INOSITOL 25MG, CHOLINE CHL 25MG/ML, In a) 5ML Vials and b) 10ML Vials, MEDAUS PHARMACY

Batch or Lot Expiration Information

Lot# a)
Lot# : 151210-40, BUD: 05/26/16
Lot# : 160229-60, BUD: 07/31/16. b)
Lot# : 151210-40, BUD: 05/26/16
Lot# : 160229-60, BUD: 07/31/16.

Recall Number: D-1186-2106

Reason for Recall
Lack of Assurance of Sterility
Initiated
05-13-2016
Reported
07-20-2016
Quantity
110 mL in Vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
74466
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.
Medaus, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S. Nationwide, Japan, and New Zealand.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-16-2017
Product Description About Product Description
Full technical description of the product.
GABA 50MG/ML (PF), 50ML Vials, MEDAUS PHARMACY

Batch or Lot Expiration Information

Lot# : 160315-14, BUD: 09/11/16

Recall Number: D-1187-2016

Reason for Recall
Lack of Assurance of Sterility
Initiated
05-13-2016
Reported
07-20-2016
Quantity
49 mL in Vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
74466
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.
Medaus, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S. Nationwide, Japan, and New Zealand.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-16-2017
Product Description About Product Description
Full technical description of the product.
GERMANIUM SESO 100MG/ML (PF), 10ML Vials, MEDAUS PHARMACY

Batch or Lot Expiration Information

Lot# : 151229-21, BUD: 06/26/16
Lot# : 151229-25, BUD: 06/26/16
Lot# : 151229-31, BUD: 06/26/16
Lot# : 160126-14, BUD: 07/24/16

Recall Number: D-1185-2016

Reason for Recall
Lack of Assurance of Sterility
Initiated
05-13-2016
Reported
07-20-2016
Quantity
500 mL in Vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
74466
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.
Medaus, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S. Nationwide, Japan, and New Zealand.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-16-2017
Product Description About Product Description
Full technical description of the product.
FOLIC ACID 10MG/ML W/PRES. (METHYLPARABEN 0.05%, PROPYLPARABEN 0.025% IN NACL, 10ML Vials, MEDAUS PHARMACY

Batch or Lot Expiration Information

Lot# : 160215-30, BUD: 08/13/16

Recall Number: D-1239-2016

Reason for Recall
Lack of Assurance of Sterility
Initiated
05-13-2016
Reported
07-20-2016
Quantity
5500 mL in Vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
74466
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.
Medaus, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S. Nationwide, Japan, and New Zealand.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-16-2017
Product Description About Product Description
Full technical description of the product.
TAURINE 50 MG/ML (PF), In a) 1ML Vials, b) 10ML Vials, and c) 20ML Vials, MEDAUS PHARMACY

Batch or Lot Expiration Information

Lot# a)
Lot# : 151202-54, BUD: 05/30/16
Lot# : 160308-31, BUD: 09/04/16. b)
Lot# : 151202-54, BUD: 05/30/16
Lot# : 160308-31, BUD: 09/04/16. c)
Lot# : 151202-54, BUD: 05/30/16
Lot# : 160308-31, BUD: 09/04/16.

Recall Number: D-1226-2016

Reason for Recall
Lack of Assurance of Sterility
Initiated
05-13-2016
Reported
07-20-2016
Quantity
21000 mL in Vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
74466
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.
Medaus, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S. Nationwide, Japan, and New Zealand.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-16-2017
Product Description About Product Description
Full technical description of the product.
MINOXIDIL 0.5% W/PRES. (BENZYL ETOH 2%), 10ML Vials, MEDAUS PHARMACY

Batch or Lot Expiration Information

Lot# : 151130-64, BUD: 05/28/16
Lot# : 151228-22, BUD: 06/25/16
Lot# : 160210-29, BUD: 08/08/16

Recall Number: D-1170-2016

Reason for Recall
Lack of Assurance of Sterility
Initiated
05-13-2016
Reported
07-20-2016
Quantity
4000 mL in Vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
74466
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.
Medaus, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S. Nationwide, Japan, and New Zealand.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-16-2017
Product Description About Product Description
Full technical description of the product.
B-COMPLEX WITHOUT B12 (PF) IN NACL 0.9%, B1-100MG, B2-5-PO4-2MG, B3-50MG, B5-2MG, B6-2MG/ML, In a) 2ML Vials and b) 5ML Vials, MEDAUS PHARMACY

Batch or Lot Expiration Information

Lot# a)
Lot# : 151130-66, BUD: 05/28/16
Lot# : 160222-51, BUD: 08/20/16. b)
Lot# : 151130-60, BUD: 05/28/16
Lot# : 160222-51, BUD: 08/20/16.

Recall Number: D-1235-2016

Reason for Recall
Lack of Assurance of Sterility
Initiated
05-13-2016
Reported
07-20-2016
Quantity
2000 mL in Vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
74466
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.
Medaus, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S. Nationwide, Japan, and New Zealand.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-16-2017
Product Description About Product Description
Full technical description of the product.
PYRIDOXINE HCL 100MG/ML (PF), In a) 2ML Vials and b) 5ML Vials, MEDAUS PHARMACY

Batch or Lot Expiration Information

Lot# a)
Lot# : 160126-20, BUD: 07/24/16. b)
Lot# : 160126-20, BUD: 07/24/16.

Recall Number: D-1243-2016

Reason for Recall
Lack of Assurance of Sterility
Initiated
05-13-2016
Reported
07-20-2016
Quantity
20 mL in Vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
74466
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.
Medaus, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S. Nationwide, Japan, and New Zealand.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-16-2017
Product Description About Product Description
Full technical description of the product.
TESTOSTERONE CYP 20 MG/ML W/PRES (BENZYL ETOH 2%), In a) 1ML Vials and b) 3ML Vials, MEDAUS PHARMACY

Batch or Lot Expiration Information

Lot# a)
Lot# : 160302-71, BUD: 08/29/16. b)
Lot# : 151207-8, BUD: 06/04/16
Lot# : 160106-34, BUD: 07/04/16
Lot# : 160208-22, BUD: 08/16/16.

Recall Number: D-1197-2016

Reason for Recall
Lack of Assurance of Sterility
Initiated
05-13-2016
Reported
07-20-2016
Quantity
500 mL in Vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
74466
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.
Medaus, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S. Nationwide, Japan, and New Zealand.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-16-2017
Product Description About Product Description
Full technical description of the product.
L-CARNITINE 500MG/ML (PF), 10ML Vials, MEDAUS PHARMACY

Batch or Lot Expiration Information

Lot# : 160203-41, BUD: 08/01/16

Recall Number: D-1213-2016

Reason for Recall
Lack of Assurance of Sterility
Initiated
05-13-2016
Reported
07-20-2016
Quantity
3000 mL in Vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
74466
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.
Medaus, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S. Nationwide, Japan, and New Zealand.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-16-2017
Product Description About Product Description
Full technical description of the product.
MANGANESE SO4 0.1MG/ML (PF), In a) 2MLVials and b) 10ML Vials, MEDAUS PHARMACY

Batch or Lot Expiration Information

Lot# a)
Lot# : 160115-24, BUD: 07/13/16
Lot# : 160302-61, BUD: 08/29/16. b)
Lot# : 160115-24, BUD: 07/13/16
Lot# : 160302-61, BUD: 08/29/16.

Recall Number: D-1198-2016

Reason for Recall
Lack of Assurance of Sterility
Initiated
05-13-2016
Reported
07-20-2016
Quantity
5000 mL in Vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
74466
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.
Medaus, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S. Nationwide, Japan, and New Zealand.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-16-2017
Product Description About Product Description
Full technical description of the product.
L-GLUTATHIONE 100MG/ML (PF), 10 ML Vials, MEDAUS PHARMACY

Batch or Lot Expiration Information

Lot# : 160222-28, BUD: 05/22/16
Lot# : 160302-63, BUD: 05/31/16

Recall Number: D-1224-2016

Reason for Recall
Lack of Assurance of Sterility
Initiated
05-13-2016
Reported
07-20-2016
Quantity
500 mL in Vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
74466
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.
Medaus, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S. Nationwide, Japan, and New Zealand.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-16-2017
Product Description About Product Description
Full technical description of the product.
M.I.C 25/50/50 W/PRES. (BENZYL ETOH 2%) METHIONINE 25MG;INOSITOL 50MG;CHOLINE CHL 50/MG/ML, In a) 5ML Vials and b) 10ML Vials, MEDAUS PHARMACY

Batch or Lot Expiration Information

Lot# a)
Lot# : 160107-17, BUD: 07/05/16. b)
Lot# : 160107-17, BUD: 07/05/16.

Recall Number: D-1217-2016

Reason for Recall
Lack of Assurance of Sterility
Initiated
05-13-2016
Reported
07-20-2016
Quantity
2000 mL in Vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
74466
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.
Medaus, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S. Nationwide, Japan, and New Zealand.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-16-2017
Product Description About Product Description
Full technical description of the product.
METHYL B12 1000MCG/ML IN NACL 0.9% (PF), 2ML Vials, MEDAUS PHARMACY

Batch or Lot Expiration Information

Lot# : 151218-28, BUD: 06/15/16

Recall Number: D-1253-2016

Reason for Recall
Lack of Assurance of Sterility
Initiated
05-13-2016
Reported
07-20-2016
Quantity
500 mL in Vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
74466
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.
Medaus, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S. Nationwide, Japan, and New Zealand.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-16-2017
Product Description About Product Description
Full technical description of the product.
ZINC SO4 1MG/ML (PF), 2ML Vials, MEDAUS PHARMACY

Batch or Lot Expiration Information

Lot# : 151217-38, BUD: 06/14/16

Recall Number: D-1195-2106

Reason for Recall
Lack of Assurance of Sterility
Initiated
05-13-2016
Reported
07-20-2016
Quantity
2000 mL in Vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
74466
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.
Medaus, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S. Nationwide, Japan, and New Zealand.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-16-2017
Product Description About Product Description
Full technical description of the product.
L-CARNITINE 50MG/ML (PF), 10ML Vials, MEDAUS PHARMACY

Batch or Lot Expiration Information

Lot# : 160303-62, BUD: 08/30/16

Recall Number: D-1208-2016

Reason for Recall
Lack of Assurance of Sterility
Initiated
05-13-2016
Reported
07-20-2016
Quantity
7000 mL in Vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
74466
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.
Medaus, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S. Nationwide, Japan, and New Zealand.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-16-2017
Product Description About Product Description
Full technical description of the product.
LIPO-INJECTION W/METHYL B12 500 MCG/CARNITINE/NO VIT C W/PRES. (BENZYL ETOH 2%) B1-50MG, B2-5 PHOS-5MG, B-3-50MG, B5-5MG, B6-5MG, METHYL B12-500MCG, LIDOCAINE-10MG, CARNITINE 25MG, METHIONINE 12.5 MG, INOSITOL 25MG, CHOLINE CHL 25MG/ML, In a) 5ML Vials and b) 10ML Vials, MEDAUS PHARMACY

Batch or Lot Expiration Information

Lot# a)
Lot# : 151228-58, BUD: 05/26/16
Lot# : 160203-6, BUD: 07/31/16. b)
Lot# : 151228-58, BUD: 05/26/16
Lot# : 160203-6, BUD: 07/31/16.

Recall Number: D-1199-2016

Reason for Recall
Lack of Assurance of Sterility
Initiated
05-13-2016
Reported
07-20-2016
Quantity
55 mL in Vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
74466
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.
Medaus, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S. Nationwide, Japan, and New Zealand.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-16-2017
Product Description About Product Description
Full technical description of the product.
L-PHENYLALANINE 15MG/ML (PF), 50ML Vials, MEDAUS PHARMACY

Batch or Lot Expiration Information

Lot# : 160308-2, BUD: 09/04/16

Recall Number: D-1227-2016

Reason for Recall
Lack of Assurance of Sterility
Initiated
05-13-2016
Reported
07-20-2016
Quantity
1000 mL in Vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
74466
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.
Medaus, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S. Nationwide, Japan, and New Zealand.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-16-2017
Product Description About Product Description
Full technical description of the product.
MOLYBDENUM 250MCG/ML (PF), 10ML Vials, MEDAUS PHARMACY

Batch or Lot Expiration Information

Lot# : 151209-24, BUD: 06/06/16

Recall Number: D-1181-2016

Reason for Recall
Lack of Assurance of Sterility
Initiated
05-13-2016
Reported
07-20-2016
Quantity
2218 mL in Vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
74466
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.
Medaus, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S. Nationwide, Japan, and New Zealand.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-16-2017
Product Description About Product Description
Full technical description of the product.
DMSO 99.9 (PF), In a) 5ML Vials and b) 10ML Vials, MEDAUS PHARMACY

Batch or Lot Expiration Information

Lot# a)
Lot# : 151217-2, BUD: 05/30/16
Lot# : 160115-6, BUD: 05/30/16
Lot# : 160303-8, BUD: 08/30/16
Lot# : 160303-10, BUD: 08/30/16. b)
Lot# : 151203-37, BUD: 05/30/16
Lot# : 151203-72, BUD: 05/30/16
Lot# : 151209-7, BUD: 05/30/16
Lot# : 151209-8, BUD: 05/30/16
Lot# : 151209-9, BUD: 05/30/16
Lot# : 151209-10, BUD: 05/30/16
Lot# : 151209-11, BUD: 05/30/16
Lot# : 151209-13, BUD: 05/30/16
Lot# : 151209-14, BUD: 05/30/16
Lot# : 160104-31, BUD: 05/30/16
Lot# : 160113-77, BUD: 05/30/16
Lot# : 151218-7, BUD: 06/15/16
Lot# : 151218-8, BUD: 06/15/16
Lot# : 160113-78, BUD: 07/11/16
Lot# : 160113-4, BUD: 07/11/16
Lot# : 160122-10, BUD: 07/20/16
Lot# : 160201-6, BUD: 07/30/16
Lot# : 160201-7, BUD: 07/30/16
Lot# : 160204-9, BUD: 08/02/16
Lot# : 160208-5, BUD: 08/06/16
Lot# : 160208-6, BUD: 08/06/16
Lot# : 160210-65, BUD: 08/08/16
Lot# : 160210-66, BUD: 08/08/16
Lot# : 160210-67, BUD: 08/08/16
Lot# : 160210-68, BUD: 08/08/16
Lot# : 160210-69, BUD: 08/08/16
Lot# : 160303-12, BUD: 08/30/16
Lot# : 160303-13, BUD: 08/30/16
Lot# : 160309-2, BUD: 09/05/16.

Recall Number: D-1254-2016

Reason for Recall
Lack of Assurance of Sterility
Initiated
05-13-2016
Reported
07-20-2016
Quantity
1000 mL in Vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
74466
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.
Medaus, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S. Nationwide, Japan, and New Zealand.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-16-2017
Product Description About Product Description
Full technical description of the product.
HCL 2MG/ML (PF), 5ML Vials, MEDAUS PHARMACY

Batch or Lot Expiration Information

Lot# : 160111-62, BUD: 07/09/16

Recall Number: D-1230-2016

Reason for Recall
Lack of Assurance of Sterility
Initiated
05-13-2016
Reported
07-20-2016
Quantity
400 mL in Vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
74466
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.
Medaus, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S. Nationwide, Japan, and New Zealand.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-16-2017
Product Description About Product Description
Full technical description of the product.
NANDROLONE DEC 200MG/ML W/PRES. (BENZYL ETOH 10%), In a) 2ML Vials, b) 4ML Vials, and c) 5ML Vials, MEDAUS PHARMACY

Batch or Lot Expiration Information

Lot# a)
Lot# : 160203-18, BUD: 08/01/16. b)
Lot# : 160203-18, BUD: 08/01/16. c)
Lot# : 160203-18, BUD: 08/01/16.

Recall Number: D-1236-2016

Reason for Recall
Lack of Assurance of Sterility
Initiated
05-13-2016
Reported
07-20-2016
Quantity
4000 mL in Vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
74466
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Medaus, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S. Nationwide, Japan, and New Zealand.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-16-2017
Product Description About Product Description
Full technical description of the product.
PYRIDOXINE HCL 100MG/ML W/PRES (BENZYL ETOH 0.02%), 5ML Vials, MEDAUS PHARMACY

Batch or Lot Expiration Information

Lot# : 151220-6, BUD: 06/17/16
Lot# : 160225-7, BUD: 08/23/16

Recall Number: D-1234-2016

Reason for Recall
Lack of Assurance of Sterility
Initiated
05-13-2016
Reported
07-20-2016
Quantity
1000 mL in Vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
74466
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.
Medaus, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S. Nationwide, Japan, and New Zealand.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-16-2017
Product Description About Product Description
Full technical description of the product.
PYRIDOXAL 50 MG/THIAMINE 50 MG/LIDOCAINE 1% NS (PF), 2ML Vials, MEDAUS PHARMACY

Batch or Lot Expiration Information

Lot# : 160104-67, BUD: 07/02/16

Recall Number: D-1216-2016

Reason for Recall
Lack of Assurance of Sterility
Initiated
05-13-2016
Reported
07-20-2016
Quantity
1000 mL in Vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
74466
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.
Medaus, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S. Nationwide, Japan, and New Zealand.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-16-2017
Product Description About Product Description
Full technical description of the product.
METHYL B12 10MG/ML (PF) IN NACL 0.9%, 1ML Vials, MEDAUS PHARMACY

Batch or Lot Expiration Information

Lot# : 160118-31, BUD: 07/16/16

Recall Number: D-1245-2016

Reason for Recall
Lack of Assurance of Sterility
Initiated
05-13-2016
Reported
07-20-2016
Quantity
150 mL in Vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
74466
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.
Medaus, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S. Nationwide, Japan, and New Zealand.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-16-2017
Product Description About Product Description
Full technical description of the product.
TESTOSTERONE CYP 50 MG/ML W/PRES (BENZYL ETOH 2%), In a) 1ML Vials, b) 2ML Vials, c) 3ML Vials, d) 4ML Vials, and e) 5ML Vials, MEDAUS PHARMACY

Batch or Lot Expiration Information

Lot# a)
Lot# : 160119-12, BUD: 07/17/16. b)
Lot# : 160119-12, BUD: 07/17/16. c)
Lot# : 160119-12, BUD: 07/17/16. d)
Lot# : 160119-12, BUD: 07/17/16. e)
Lot# : 160119-12, BUD: 07/17/16.

Recall Number: D-1219-2016

Reason for Recall
Lack of Assurance of Sterility
Initiated
05-13-2016
Reported
07-20-2016
Quantity
331 mL in Vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
74466
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.
Medaus, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S. Nationwide, Japan, and New Zealand.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-16-2017
Product Description About Product Description
Full technical description of the product.
METHYL B12 10MG/ML W/PRES (BENZALKONIUM 0.01%) IN NACL 0.9%, In a) 1ML Vials, b) 5ML Vials, and c) 10ML Vials, MEDAUS PHARMACY

Batch or Lot Expiration Information

Lot# a)
Lot# : 160201-11, BUD: 07/11/16
Lot# : 160215-13, BUD: 07/11/16
Lot# : 160309-4, BUD: 07/11/16. b)
Lot# : 160315-1, BUD: 07/11/16
Lot# : 160201-11, BUD: 07/11/16
Lot# : 160210-71, BUD: 07/11/16
Lot# : 160309-4, BUD: 07/11/16. c)
Lot# : 160125-17, BUD: 07/11/16
Lot# : 160210-35, BUD: 07/11/16
Lot# : 160222-20, BUD: 07/11/16
Lot# : 160204-46, BUD: 07/11/16
Lot# : 160307-25, BUD: 07/11/16.

Recall Number: D-1204-2016

Reason for Recall
Lack of Assurance of Sterility
Initiated
05-13-2016
Reported
07-20-2016
Quantity
155 mL in Vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
74466
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.
Medaus, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S. Nationwide, Japan, and New Zealand.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-16-2017
Product Description About Product Description
Full technical description of the product.
LIPO B CYANO 1MG/ML W/PRES. (BENZYL ETOH 1%) METHIONINE 25MG, INOSITOL 50MG, CHOLINE CHL-50MG, CYANO B-12-100MCG, BENZYL ALCOHOL 1%/ML, In a) 5ML Vials and b) 10ML Vials, MEDAUS PHARMACY

Batch or Lot Expiration Information

Lot# a)
Lot# : 151203-50, BUD: 05/26/16
Lot# : 160128-34, BUD: 07/26/16
Lot# : 160229-51, BUD: 07/31/16. b)
Lot# : 151204-10, BUD: 05/26/16
Lot# : 151204-19, BUD: 05/26/16.

Recall Number: D-1223-2016

Reason for Recall
Lack of Assurance of Sterility
Initiated
05-13-2016
Reported
07-20-2016
Quantity
1430 mL in Vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
74466
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.
Medaus, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S. Nationwide, Japan, and New Zealand.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-16-2017
Product Description About Product Description
Full technical description of the product.
M.I.C B-COMPLEX W/PRES. (BENZYL ETOH 2%) B1-50MG;B2-5-PO4-5MG;B3-50MG;B5-5MG;B6-5MG; CYANO B12 100MCG; CHOLINE CHL-50MG; INOSITOL-25MG;METHIONINE 12.5MG/ML, 5ML Vials, MEDAUS PHARMACY

Batch or Lot Expiration Information

Lot# : 160119-59; BUD: 05/26/16
Lot# : 151228-72; BUD: 05/26/16
Lot# : 160127-4; BUD: 05/26/16
Lot# : 160201-13; BUD: 05/26/16
Lot# : 160202-13; BUD: 05/26/16
Lot# : 160204-11; BUD: 05/26/16
Lot# : 160202-66; BUD: 06/11/16
Lot# : 160307-31; BUD: 06/11/16
Lot# : 160224-68; BUD: 06/11/16
Lot# : 160205-8; BUD: 06/11/16

Recall Number: D-1244-2016

Reason for Recall
Lack of Assurance of Sterility
Initiated
05-13-2016
Reported
07-20-2016
Quantity
13 mL in Vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
74466
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.
Medaus, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S. Nationwide, Japan, and New Zealand.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-16-2017
Product Description About Product Description
Full technical description of the product.
TESTOSTERONE CYP 25 MG/ML W/PRES (BENZYL ETOH 2%), 5ML Vials, MEDAUS PHARMACY

Batch or Lot Expiration Information

Lot# : 160115-20, BUD: 07/13/16

Recall Number: D-1178-2016

Reason for Recall
Lack of Assurance of Sterility
Initiated
05-13-2016
Reported
07-20-2016
Quantity
3500 mL in Vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
74466
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.
Medaus, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S. Nationwide, Japan, and New Zealand.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-16-2017
Product Description About Product Description
Full technical description of the product.
DEXPANTHENOL 250MG/ML (PF), In a) 2ML Vials and b) 5ML Vials, MEDAUS PHARMACY

Batch or Lot Expiration Information

Lot# a)
Lot# : 151217-31, BUD: 06/14/16. b)
Lot# : 151217-31, BUD: 06/14/16.

Recall Number: D-1248-2016

Reason for Recall
Lack of Assurance of Sterility
Initiated
05-13-2016
Reported
07-20-2016
Quantity
85 mL in Vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
74466
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.
Medaus, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S. Nationwide, Japan, and New Zealand.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-16-2017
Product Description About Product Description
Full technical description of the product.
TMG 100 MG/ML (PF), 10ML Vials, MEDAUS PHARMACY

Batch or Lot Expiration Information

Lot# : 160215-23, BUD: 08/13/16

Recall Number: D-1182-2016

Reason for Recall
Lack of Assurance of Sterility
Initiated
05-13-2016
Reported
07-20-2016
Quantity
24000 mL in Vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
74466
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.
Medaus, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S. Nationwide, Japan, and New Zealand.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-16-2017
Product Description About Product Description
Full technical description of the product.
EDTA DISODIUM 15% (150MG/ML), 20ML Vials, MEDAUS PHARMACY

Batch or Lot Expiration Information

Lot# : 151202-45, BUD: 05/30/16
Lot# : 160105-38, BUD: 07/03/16
Lot# : 160114-20, BUD: 07/12/16
Lot# : 160217-28, BUD: 08/15/16

Recall Number: D-1193-2016

Reason for Recall
Lack of Assurance of Sterility
Initiated
05-13-2016
Reported
07-20-2016
Quantity
300 mL in Vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
74466
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.
Medaus, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S. Nationwide, Japan, and New Zealand.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-16-2017
Product Description About Product Description
Full technical description of the product.
HYDROXY B12 1000MCG/ML IN NACL 0.9% (PF), 1ML Vials, MEDAUS PHARMACY

Batch or Lot Expiration Information

Lot# : 160104-64, BUD: 07/02/16

Recall Number: D-1218-2016

Reason for Recall
Lack of Assurance of Sterility
Initiated
05-13-2016
Reported
07-20-2016
Quantity
600 mL in Vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
74466
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.
Medaus, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S. Nationwide, Japan, and New Zealand.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-16-2017
Product Description About Product Description
Full technical description of the product.
METHYL B12 5MG/ML (PF) IN NACL 0.9%, 1ML Vials, MEDAUS PHARMACY

Batch or Lot Expiration Information

Lot# : 151123-25, BUD: 05/21/16
Lot# : 160126-12, BUD: 07/24/16

Recall Number: D-1221-2016

Reason for Recall
Lack of Assurance of Sterility
Initiated
05-13-2016
Reported
07-20-2016
Quantity
3000 mL in Vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
74466
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.
Medaus, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S. Nationwide, Japan, and New Zealand.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-16-2017
Product Description About Product Description
Full technical description of the product.
M.I.C./B-COMPLEX (PF) B1-50MG;B2-5-PO4-5MG;B3-50MG;B6-5MG; CYANO B12 100MCG; CHOLINE CHL-5MG; INOSITOL-25MG;METHIONINE 12.5MG/ML, 2ML Vials, MEDAUS PHARMACY

Batch or Lot Expiration Information

Lot# : 151220-5, BUD: 05/26/16
Lot# : 160127-25, BUD: 07/25/16

Recall Number: D-1246-2016

Reason for Recall
Lack of Assurance of Sterility
Initiated
05-13-2016
Reported
07-20-2016
Quantity
1000 mL in Vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
74466
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.
Medaus, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S. Nationwide, Japan, and New Zealand.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-16-2017
Product Description About Product Description
Full technical description of the product.
THIAMINE 100 MG/ML, 2ML Vials, MEDAUS PHARMACY

Batch or Lot Expiration Information

Lot# : 151210-17, BUD: 06/07/16

Recall Number: D-1168-2016

Reason for Recall
Lack of Assurance of Sterility
Initiated
05-13-2016
Reported
07-20-2016
Quantity
380 mL in Vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
74466
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.
Medaus, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S. Nationwide, Japan, and New Zealand.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-16-2017
Product Description About Product Description
Full technical description of the product.
B-COMPLEX #3 W/PRES (BENZYL ETOH 2%), B1-100MG, B2-5-PO4-2MG, B3-100MG, B5-2MG, B6-2MG/ML, 10ML Vials, MEDAUS PHARMACY

Batch or Lot Expiration Information

Lot# : 160115-3, BUD: 06/11/16
Lot# : 160202-10, BUD: 06/11/16
Lot# : 160204-43, BUD: 06/11/16
Lot# : 160223-3, BUD: 06/11/16
Lot# : 160307-26, BUD: 06/11/16
Lot# : 160309-1, BUD: 06/11/16

Recall Number: D-1211-216

Reason for Recall
Lack of Assurance of Sterility
Initiated
05-13-2016
Reported
07-20-2016
Quantity
5000 mL in Vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
74466
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.
Medaus, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S. Nationwide, Japan, and New Zealand.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-16-2017
Product Description About Product Description
Full technical description of the product.
MAGNESIUM CHL 200MG/ML (PF), In a) 5ML Vials and b) 10ML Vials, MEDAUS PHARMACY

Batch or Lot Expiration Information

Lot# a)
Lot# : 160203-19, BUD: 08/01/16
Lot# : 160222-60, BUD: 08/20/16. b)
Lot# : 160203-19, BUD: 08/01/16
Lot# : 160222-60, BUD: 08/20/16.