Multi-event October 2013 FDA Recall Drug by Specialty Medicine Compounding Pharmacy

This Multi-event Class II drug recall was voluntarily initiated by Specialty Medicine Compounding Pharmacy on October 19, 2013 for the product Drug. The FDA reported the reason for recall as lack of assurance of sterility. The product was distributed in Hospitals, clinics, physicians, and patients in the Michigan area only. and the recall is currently terminated.

Reported Recall Events

D-437-2014 TERMINATED D-449-2014 TERMINATED D-451-2014 TERMINATED D-459-2014 TERMINATED D-412-2014 TERMINATED D-414-2014 TERMINATED D-455-2014 TERMINATED D-432-2014 TERMINATED D-431-2014 TERMINATED D-423-2014 TERMINATED D-428-2014 TERMINATED D-440-2014 TERMINATED D-442-2014 TERMINATED D-417-2014 TERMINATED D-426-2014 TERMINATED D-446-2014 TERMINATED D-456-2014 TERMINATED D-443-2014 TERMINATED D-419-2014 TERMINATED D-430-2014 TERMINATED D-453-2014 TERMINATED D-413-2014 TERMINATED D-450-2014 TERMINATED D-445-2014 TERMINATED D-435-2014 TERMINATED D-424-2014 TERMINATED D-436-2014 TERMINATED D-452-2014 TERMINATED D-447-2014 TERMINATED D-444-2014 TERMINATED D-411-2014 TERMINATED D-421-2014 TERMINATED D-415-2014 TERMINATED D-416-2014 TERMINATED D-439-2014 TERMINATED D-420-2014 TERMINATED D-418-2014 TERMINATED D-425-2014 TERMINATED D-454-2014 TERMINATED D-433-2014 TERMINATED D-434-2014 TERMINATED D-438-2014 TERMINATED D-410-2014 TERMINATED D-458-2014 TERMINATED D-429-2014 TERMINATED D-422-2014 TERMINATED D-427-2014 TERMINATED D-448-2014 TERMINATED D-441-2014 TERMINATED D-457-2014 TERMINATED D-460-2014 TERMINATED

Recall Number: D-437-2014

Reason for Recall
Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.
Initiated
10-19-2013
Reported
01-22-2014
Quantity
1351 mL

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
66566
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.
Specialty Medicine Compounding Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Hospitals, clinics, physicians, and patients in the Michigan area only.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-22-2014
Product Description About Product Description
Full technical description of the product.
Papaverine HCL, 30 mg/mL injectable, also labeled as (10 mL) and (2 mL), Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

Batch or Lot Expiration Information

Lot# All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including
Lot# s: 08212013@13, 09112013@2, 09172013@17, 09232013@1, 09242013@13, 10022013@7, 09242013@14, 10022013@9, 10032013@5, 10072013@2

Recall Number: D-449-2014

Reason for Recall
Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.
Initiated
10-19-2013
Reported
01-22-2014
Quantity
33 mL

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
66566
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.
Specialty Medicine Compounding Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Hospitals, clinics, physicians, and patients in the Michigan area only.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-22-2014
Product Description About Product Description
Full technical description of the product.
TESTOS CYPIONATE* IN OIL 100 mg/mL INJECTABLE, TESTOS CYPIONATE* IN OIL 200 mg/mL INJECTABLE, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

Batch or Lot Expiration Information

Lot# All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including
Lot# s: 09182013@42, t09172013@31, t09182013@4

Recall Number: D-451-2014

Reason for Recall
Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.
Initiated
10-19-2013
Reported
01-22-2014
Quantity
3000 mL

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
66566
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.
Specialty Medicine Compounding Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Hospitals, clinics, physicians, and patients in the Michigan area only.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-22-2014
Product Description About Product Description
Full technical description of the product.
TRANEXAMIC ACID* 2 g/75 mL SOLUTION, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

Batch or Lot Expiration Information

Lot# All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including
Lot# s: 08282013@8, 09192013@9, 10142013@2

Recall Number: D-459-2014

Reason for Recall
Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.
Initiated
10-19-2013
Reported
01-22-2014
Quantity
a) Injectable 600 mL; b) Topical 800 mL

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
66566
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.
Specialty Medicine Compounding Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Hospitals, clinics, physicians, and patients in the Michigan area only.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-22-2014
Product Description About Product Description
Full technical description of the product.
DT- Tranexamic Acid* 2 gm/100 mL Drug Study -IV 100 mL injectable, DT-, DT-Tranexamic Acid* 2 gm/100 mL-Drug Study-Topical 100 mL Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

Batch or Lot Expiration Information

Lot# All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including
Lot# s: a) Injectable 09252013@10, 09302013@1, 10152013@5, ; b) Topical 09252013@11, 09302013@3, 10152013@7

Recall Number: D-412-2014

Reason for Recall
Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.
Initiated
10-19-2013
Reported
01-22-2014
Quantity
2801 doses

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
66566
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.
Specialty Medicine Compounding Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Hospitals, clinics, physicians, and patients in the Michigan area only.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-22-2014
Product Description About Product Description
Full technical description of the product.
Bevacizumab, (repackaged) in a) 0.11 mL and b) 0.06 mL, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

Batch or Lot Expiration Information

Lot# All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including
Lot# s: for both sizes: 08072013@26, 08282013@52, 09112013@31, 09162013@33, 10072013@33, 07242013@47, 08082013@42, 09172013@52, 10162013@35, 07242013@55, 07242013@56, 09122013@36, 09122013@35, 10042013@8, 10042013@9, 07262013@12, 07262013@13, 07262013@14, 07262013@16, 08082013@35, 08082013@41, 08152013@44, 08162013@21, 08292013@53, 08302013@24, 08302013@25, 08302013@35, 09062013@20, 09132013@26, 09132013@12, 09132013@13, 09202013@34, 09202013@35, 09202013@36, 09262013@24, 10092013@36, 10092013@39, 10102013@37, 10112013@34, 10162013@44, 10172013@26, 10172013@27

Recall Number: D-414-2014

Reason for Recall
Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.
Initiated
10-19-2013
Reported
01-22-2014
Quantity
38 doses

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
66566
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.
Specialty Medicine Compounding Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Hospitals, clinics, physicians, and patients in the Michigan area only.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-22-2014
Product Description About Product Description
Full technical description of the product.
Combo Eye Gel, HF COMBO EYE GEL* (cyclopentolate 2%, tropicamide 1%, diclofenac sodium 0.1%, ciprofloxacin 0.3%, phenylephrine 10%, lidocaine jelly 2%), Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

Batch or Lot Expiration Information

Lot# All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including
Lot# s: 10092013@4, 10162013@1

Recall Number: D-455-2014

Reason for Recall
Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.
Initiated
10-19-2013
Reported
01-22-2014
Quantity
204 doses

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
66566
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.
Specialty Medicine Compounding Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Hospitals, clinics, physicians, and patients in the Michigan area only.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-22-2014
Product Description About Product Description
Full technical description of the product.
VIGAMOX (moxifloxacin)* IN BSS (0.15 %) 0.75 mg/0.5 mL PREF SYRINGE, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

Batch or Lot Expiration Information

Lot# All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including
Lot# s: 10012013@23, 10012013@24, 10012013@25, 10012013@9, 10012013@12, 10012013@13, 10012013@15, 10012013@16, 10012013@17, 10012013@19, 10012013@20, 10012013@22

Recall Number: D-432-2014

Reason for Recall
Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.
Initiated
10-19-2013
Reported
01-22-2014
Quantity
186 mL

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
66566
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.
Specialty Medicine Compounding Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Hospitals, clinics, physicians, and patients in the Michigan area only.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-22-2014
Product Description About Product Description
Full technical description of the product.
Multitrace-4 pediatric injection ( zinc sulfate usp granular heptahydrate, cupric sulfate pentahydrate usp, manganese sulfate monohydrate usp, chromium chloride hexahydrate), Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

Batch or Lot Expiration Information

Lot# All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including
Lot# s: 09242013@10, 07012013@12, 07092013@14, 08132013@22, 08282013@1

Recall Number: D-431-2014

Reason for Recall
Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.
Initiated
10-19-2013
Reported
01-22-2014
Quantity
726.45 mL

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
66566
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.
Specialty Medicine Compounding Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Hospitals, clinics, physicians, and patients in the Michigan area only.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-22-2014
Product Description About Product Description
Full technical description of the product.
METHYLCOBALAMIN * 10 mg/mL INJECTABLE, METHYLCOBALAMIN * UD/PF 25 mg/mL INJECTABLE, METHYLCOBALAMIN* 1000 mcg/mL INJECTABLE, METHYLCOBALAMIN* 25 mg/mL INJECTABLE, METHYLCOBALAMIN* 5000 mcg/mL INJECTABLE, METHYLCOBALAMIN* PF 1000 mcg/mL PREF SYRINGE, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

Batch or Lot Expiration Information

Lot# All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including
Lot# s: t10072013@4, 10192013@1, 07112013@3, 09052013@6, 09262013@2, 09272013@35, 10012013@26, 08282013@35, t08282013@17, t10092013@30, t10102013@18, t08222013@11, t08292013@21, t08302013@5, t09162013@30, 09162013@46, 09172013@23, t09242013@33, t09302013@25, t10022013@15, t10112013@21, t10162013@4, t08222013@21, t10092013@29

Recall Number: D-423-2014

Reason for Recall
Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.
Initiated
10-19-2013
Reported
01-22-2014
Quantity
126 mL

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
66566
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.
Specialty Medicine Compounding Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Hospitals, clinics, physicians, and patients in the Michigan area only.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-22-2014
Product Description About Product Description
Full technical description of the product.
Glutathione PF, 60 mg/mL inhalation, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

Batch or Lot Expiration Information

Lot# All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including
Lot# : 10112013@1

Recall Number: D-428-2014

Reason for Recall
Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.
Initiated
10-19-2013
Reported
01-22-2014
Quantity
65 mL

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
66566
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.
Specialty Medicine Compounding Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Hospitals, clinics, physicians, and patients in the Michigan area only.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-22-2014
Product Description About Product Description
Full technical description of the product.
LIDOCAINE/SODIUM CHL* 0.4 %/18 % INJECTABLE; all sizes, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

Batch or Lot Expiration Information

Lot# All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including
Lot# s: t08142013@39, t09052013@40, t09122013@3, t09122013@25

Recall Number: D-440-2014

Reason for Recall
Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.
Initiated
10-19-2013
Reported
01-22-2014
Quantity
10 mL

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
66566
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.
Specialty Medicine Compounding Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Hospitals, clinics, physicians, and patients in the Michigan area only.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-22-2014
Product Description About Product Description
Full technical description of the product.
Polidocanol, 3% injectable, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

Batch or Lot Expiration Information

Lot# All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including
Lot# : t07312013@28

Recall Number: D-442-2014

Reason for Recall
Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.
Initiated
10-19-2013
Reported
01-22-2014
Quantity
6 mL

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
66566
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.
Specialty Medicine Compounding Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Hospitals, clinics, physicians, and patients in the Michigan area only.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-22-2014
Product Description About Product Description
Full technical description of the product.
Proparacaine HCl PF, 0.5% ophthalmic solution, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

Batch or Lot Expiration Information

Lot# All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including
Lot# : 09302013@8

Recall Number: D-417-2014

Reason for Recall
Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.
Initiated
10-19-2013
Reported
01-22-2014
Quantity
70 mL

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
66566
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.
Specialty Medicine Compounding Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Hospitals, clinics, physicians, and patients in the Michigan area only.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-22-2014
Product Description About Product Description
Full technical description of the product.
DEXAMETHASONE NAPO4* PF 4MG/ML SOLUTION, all sizes, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

Batch or Lot Expiration Information

Lot# All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including
Lot# s: 09112013@1, 09232013@40, t09252013@26

Recall Number: D-426-2014

Reason for Recall
Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.
Initiated
10-19-2013
Reported
01-22-2014
Quantity
70 mL

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
66566
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.
Specialty Medicine Compounding Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Hospitals, clinics, physicians, and patients in the Michigan area only.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-22-2014
Product Description About Product Description
Full technical description of the product.
HYDROXOCOBALAMIN* 10,000 mcg/mL INJECTABLE, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

Batch or Lot Expiration Information

Lot# All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including
Lot# s: t08122013@18, t09232013@8

Recall Number: D-446-2014

Reason for Recall
Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.
Initiated
10-19-2013
Reported
01-22-2014
Quantity
180 mL

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
66566
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.
Specialty Medicine Compounding Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Hospitals, clinics, physicians, and patients in the Michigan area only.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-22-2014
Product Description About Product Description
Full technical description of the product.
Sodium Thiosulfate PF, 10 % injectable, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

Batch or Lot Expiration Information

Lot# All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including
Lot# s: t10022013@6, 10162013@3, t10172013@10

Recall Number: D-456-2014

Reason for Recall
Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.
Initiated
10-19-2013
Reported
01-22-2014
Quantity
a) 1900 injectable; b) 1900 mL topical

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
66566
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.
Specialty Medicine Compounding Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Hospitals, clinics, physicians, and patients in the Michigan area only.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-22-2014
Product Description About Product Description
Full technical description of the product.
WB-Tranexamic acid, 2 g/Placebo 100 mL, DRUG STUDY, packaged as a) 100 mL INJECTABLE, b) TOPICAL, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

Batch or Lot Expiration Information

Lot# All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including
Lot# s: a) Injectable lots: 09272013@14, 09272013@4, 09272013@8, 09272013@18, 10142013@3, 10142013@9, 10142013@13, 10142013@15, 10142013@19, 09272013@3, 09272013@7, 09272013@11, 09272013@13, 09272013@17, 10142013@6, 10142013@8, 10142013@12, 10142013@18, 10142013@22; b) Topical lots: 09272013@2, 09272013@6, 09272013@10, 09272013@12, 09272013@16, 10142013@5, 10142013@7, 10142013@11, 10142013@17, 10142013@21, 09272013@5, 09272013@9, 09272013@15, 09272013@19, 10142013@4, 10142013@10, 10142013@14, 10142013@16, 10142013@20

Recall Number: D-443-2014

Reason for Recall
Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.
Initiated
10-19-2013
Reported
01-22-2014
Quantity
86 mL

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
66566
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.
Specialty Medicine Compounding Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Hospitals, clinics, physicians, and patients in the Michigan area only.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-22-2014
Product Description About Product Description
Full technical description of the product.
QUAD MIX* 0.05 mg/25 mg/2 mg/25 mcg/mL INJECTABLE, QUAD MIX* 0.1 mg/30 mg/2 mg/20 mcg INJECTABLE, QUAD MIX* 0.1 mg/30 mg/2 mg/50 mcg INJECTABLE, QUAD MIX* 0.1 mg/9 mg/1 mg/10 mcg/mL INJECTABLE, SUPER QUAD MIX* 0.1 mg/30 mg/2 mg/20 mcg INJECTABLE, (pavaperine HCl, phentolamine, prostaglandin, atropine sulfate), Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

Batch or Lot Expiration Information

Lot# All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including
Lot# s:t09192013@20, t07312013@12, t07312013@13, t09172013@30, t08142013@10, t08272013@28, t09052013@32, 09162013@40, t09252013@12

Recall Number: D-419-2014

Reason for Recall
Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.
Initiated
10-19-2013
Reported
01-22-2014
Quantity
157.08 mL

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
66566
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.
Specialty Medicine Compounding Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Hospitals, clinics, physicians, and patients in the Michigan area only.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-22-2014
Product Description About Product Description
Full technical description of the product.
EPINEPHRINE PF SF* (0.3 mL); (1 mL), (0.5 mL IN 3 mL SYRINGE) 1:1000 OPHTH SOL, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

Batch or Lot Expiration Information

Lot# All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including
Lot# s: 10082013@7, 10152013@2, t10102013@1, t10092013@7, t10092013@6, t10142013@60, t10142013@61

Recall Number: D-430-2014

Reason for Recall
Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.
Initiated
10-19-2013
Reported
01-22-2014
Quantity
20 mL

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
66566
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.
Specialty Medicine Compounding Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Hospitals, clinics, physicians, and patients in the Michigan area only.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-22-2014
Product Description About Product Description
Full technical description of the product.
METHOCARBAMOL (REPACK) 100 mg/mL INJECTABLE, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

Batch or Lot Expiration Information

Lot# All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including
Lot# : 10042013@1

Recall Number: D-453-2014

Reason for Recall
Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.
Initiated
10-19-2013
Reported
01-22-2014
Quantity
44 mL

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
66566
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.
Specialty Medicine Compounding Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Hospitals, clinics, physicians, and patients in the Michigan area only.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-22-2014
Product Description About Product Description
Full technical description of the product.
TRIPLE MIX* 15 mg/1 mg/20 mcg/mL INJECTABLE, TRIPLE MIX* 30 mg/1 mg/20 mcg/mL INJECTABLE (papaverine hydrochloride, phentolamine, prostaglandin), Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

Batch or Lot Expiration Information

Lot# All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including
Lot# s: t09032013@48, t09252013@37, 09162013@38

Recall Number: D-413-2014

Reason for Recall
Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.
Initiated
10-19-2013
Reported
01-22-2014
Quantity
44.44 mL

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
66566
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.
Specialty Medicine Compounding Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Hospitals, clinics, physicians, and patients in the Michigan area only.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-22-2014
Product Description About Product Description
Full technical description of the product.
Ceftazidime, 22.5 mg/ml (ophthalmic), Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

Batch or Lot Expiration Information

Lot# All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including
Lot# : 08222013@3

Recall Number: D-450-2014

Reason for Recall
Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.
Initiated
10-19-2013
Reported
01-22-2014
Quantity
17.5 ml

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
66566
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.
Specialty Medicine Compounding Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Hospitals, clinics, physicians, and patients in the Michigan area only.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-22-2014
Product Description About Product Description
Full technical description of the product.
TESTOS CYPIONATE* IN OLIVE OIL 200 mg/mL INJECTABLE, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

Batch or Lot Expiration Information

Lot# All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including
Lot# : 08192013@34, t08272013@34, t10012013@28

Recall Number: D-445-2014

Reason for Recall
Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.
Initiated
10-19-2013
Reported
01-22-2014
Quantity
100 mL

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
66566
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.
Specialty Medicine Compounding Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Hospitals, clinics, physicians, and patients in the Michigan area only.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-22-2014
Product Description About Product Description
Full technical description of the product.
Sodium tetradecyl SO4, 3% injectable, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

Batch or Lot Expiration Information

Lot# All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including
Lot# s: t08302013@12

Recall Number: D-435-2014

Reason for Recall
Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.
Initiated
10-19-2013
Reported
01-22-2014
Quantity
5582.6 mL

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
66566
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.
Specialty Medicine Compounding Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Hospitals, clinics, physicians, and patients in the Michigan area only.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-22-2014
Product Description About Product Description
Full technical description of the product.
Neomycin Sulfate* ophthalmic solution, 333 mg/mL, all sizes, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

Batch or Lot Expiration Information

Lot# All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including
Lot# s: 09242013@8, 09242013@3, 09242013@4, 09242013@6, 09242013@7, 09242013@9, 10012013@1, 10012013@2, 10012013@3, 10012013@4, 10012013@5, 10012013@6, 10032013@6, 10142013@1

Recall Number: D-424-2014

Reason for Recall
Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.
Initiated
10-19-2013
Reported
01-22-2014
Quantity
210 mL

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
66566
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.
Specialty Medicine Compounding Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Hospitals, clinics, physicians, and patients in the Michigan area only.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-22-2014
Product Description About Product Description
Full technical description of the product.
GLYCERIN-CHROMATED (W/V)* 72% INJECTABLE, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

Batch or Lot Expiration Information

Lot# All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including
Lot# s: 07082013@7, t07112013@1, 08022013@9, t08142013@35, t08222013@15, t10042013@2

Recall Number: D-436-2014

Reason for Recall
Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.
Initiated
10-19-2013
Reported
01-22-2014
Quantity
35.5 mL

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
66566
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.
Specialty Medicine Compounding Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Hospitals, clinics, physicians, and patients in the Michigan area only.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-22-2014
Product Description About Product Description
Full technical description of the product.
Papav/Phentol/PG E1, 30 mg/1 mg/20 mcg/mL, injectable, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

Batch or Lot Expiration Information

Lot# All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including
Lot# s: t07312013@20, t09162013@43, t08282013@18, t08292013@11

Recall Number: D-452-2014

Reason for Recall
Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.
Initiated
10-19-2013
Reported
01-22-2014
Quantity
5.5 mL

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
66566
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.
Specialty Medicine Compounding Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Hospitals, clinics, physicians, and patients in the Michigan area only.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-22-2014
Product Description About Product Description
Full technical description of the product.
TROPICAMIDE* 1% OPHTHALMIC SOLUTION, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

Batch or Lot Expiration Information

Lot# All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including
Lot# : t10142013@30

Recall Number: D-447-2014

Reason for Recall
Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.
Initiated
10-19-2013
Reported
01-22-2014
Quantity
420 mL

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
66566
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.
Specialty Medicine Compounding Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Hospitals, clinics, physicians, and patients in the Michigan area only.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-22-2014
Product Description About Product Description
Full technical description of the product.
HYDROXYPROGEST*-17ALPHA -PF 250 mg/mL INJECTABLE, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

Batch or Lot Expiration Information

Lot# All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including
Lot# s: 07122013@1, 09162013@6

Recall Number: D-444-2014

Reason for Recall
Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.
Initiated
10-19-2013
Reported
01-22-2014
Quantity
9200 mL

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
66566
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.
Specialty Medicine Compounding Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Hospitals, clinics, physicians, and patients in the Michigan area only.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-22-2014
Product Description About Product Description
Full technical description of the product.
SODIUM PHOSPHATE* PF 3MMOL/mL INJECTABLE, SODIUM PHOSPHATE* PF(15 mL) 3MMOL/mL INJECTABLE, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

Batch or Lot Expiration Information

Lot# All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including
Lot# s: 09242013@11, 09242013@12, 10022013@1, 10022013@2, 10082013@1, 10082013@2, 10082013@3, 10092013@1, 10092013@2, 10092013@3, 10152013@15, 09192013@1, 09192013@2, 09192013@3, 09192013@4, 09192013@6, 09192013@7, 09192013@8, 09202013@28, 09202013@29, 10032013@3, 10032013@4, 10152013@3, 10152013@4

Recall Number: D-411-2014

Reason for Recall
Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.
Initiated
10-19-2013
Reported
01-22-2014
Quantity
160 grams

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
66566
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.
Specialty Medicine Compounding Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Hospitals, clinics, physicians, and patients in the Michigan area only.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-22-2014
Product Description About Product Description
Full technical description of the product.
Aluminum Potassium Sulfate Sterile powder, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

Batch or Lot Expiration Information

Lot# All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including
Lot# s: 08132013@1, 08162013@5

Recall Number: D-421-2014

Reason for Recall
Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.
Initiated
10-19-2013
Reported
01-22-2014
Quantity
4.4 mL

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
66566
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.
Specialty Medicine Compounding Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Hospitals, clinics, physicians, and patients in the Michigan area only.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-22-2014
Product Description About Product Description
Full technical description of the product.
FLUOROURACIL* PF 50 mg/mL INJECTABLE, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

Batch or Lot Expiration Information

Lot# All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including
Lot# : 09242013@1

Recall Number: D-415-2014

Reason for Recall
Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.
Initiated
10-19-2013
Reported
01-22-2014
Quantity
180 mL

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
66566
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.
Specialty Medicine Compounding Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Hospitals, clinics, physicians, and patients in the Michigan area only.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-22-2014
Product Description About Product Description
Full technical description of the product.
Cyanocobalamin, 1000 mcg/ml; injectable, all sizes, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

Batch or Lot Expiration Information

Lot# All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including
Lot# : t08162013@15

Recall Number: D-416-2014

Reason for Recall
Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.
Initiated
10-19-2013
Reported
01-22-2014
Quantity
5 mL

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
66566
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.
Specialty Medicine Compounding Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Hospitals, clinics, physicians, and patients in the Michigan area only.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-22-2014
Product Description About Product Description
Full technical description of the product.
CYCLOPENTOLATE HCL* (FOR COMPOUNDING) 2% OPHTHALMIC, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

Batch or Lot Expiration Information

Lot# All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including
Lot# : 09262013@1

Recall Number: D-439-2014

Reason for Recall
Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.
Initiated
10-19-2013
Reported
01-22-2014
Quantity
6 mL

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
66566
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.
Specialty Medicine Compounding Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Hospitals, clinics, physicians, and patients in the Michigan area only.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-22-2014
Product Description About Product Description
Full technical description of the product.
Phenylephrine/Tropicamide 2.5 %/1 % ophthalmic solution, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

Batch or Lot Expiration Information

Lot# All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including
Lot# : 09302013@6

Recall Number: D-420-2014

Reason for Recall
Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.
Initiated
10-19-2013
Reported
01-22-2014
Quantity
700 mL

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
66566
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.
Specialty Medicine Compounding Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Hospitals, clinics, physicians, and patients in the Michigan area only.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-22-2014
Product Description About Product Description
Full technical description of the product.
FLUCON/GENT* (fluconazole and gentamicin) 200 mg/480 mg/1 L SOLUTION, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

Batch or Lot Expiration Information

Lot# All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including
Lot# : 10042013@7

Recall Number: D-418-2014

Reason for Recall
Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.
Initiated
10-19-2013
Reported
01-22-2014
Quantity
30 mL

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
66566
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.
Specialty Medicine Compounding Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Hospitals, clinics, physicians, and patients in the Michigan area only.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-22-2014
Product Description About Product Description
Full technical description of the product.
EDETATE DISODIUM* (0.05M) 1.7% OPHTH SOL, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

Batch or Lot Expiration Information

Lot# All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including
Lot# s: t07312013@36, t09182013@5

Recall Number: D-425-2014

Reason for Recall
Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.
Initiated
10-19-2013
Reported
01-22-2014
Quantity
148.075 ml

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
66566
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.
Specialty Medicine Compounding Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Hospitals, clinics, physicians, and patients in the Michigan area only.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-22-2014
Product Description About Product Description
Full technical description of the product.
Hyaluronidase, pf 100U/mL; pf 150 U/mL, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

Batch or Lot Expiration Information

Lot# All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including
Lot# s:09232013@3, 09102013@5, t09172013@20, 09252013@4, 09252013@7, 10022013@12, 10082013@6, 10142013@58, 10152013@1

Recall Number: D-454-2014

Reason for Recall
Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.
Initiated
10-19-2013
Reported
01-22-2014
Quantity
50 mL

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
66566
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.
Specialty Medicine Compounding Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Hospitals, clinics, physicians, and patients in the Michigan area only.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-22-2014
Product Description About Product Description
Full technical description of the product.
VANCOMYCIN HCL 10 mg/mL OPHTHALMIC SOLUTION, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

Batch or Lot Expiration Information

Lot# All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including
Lot# : 08222013@2

Recall Number: D-433-2014

Reason for Recall
Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.
Initiated
10-19-2013
Reported
01-22-2014
Quantity
120 mL

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
66566
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.
Specialty Medicine Compounding Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Hospitals, clinics, physicians, and patients in the Michigan area only.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-22-2014
Product Description About Product Description
Full technical description of the product.
NALOXONE HCL* 0.4MG/ML INJECTABLE, all sizes, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

Batch or Lot Expiration Information

Lot# All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including
Lot# : 08292013@10

Recall Number: D-434-2014

Reason for Recall
Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.
Initiated
10-19-2013
Reported
01-22-2014
Quantity
100 mL

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
66566
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.
Specialty Medicine Compounding Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Hospitals, clinics, physicians, and patients in the Michigan area only.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-22-2014
Product Description About Product Description
Full technical description of the product.
NALTREXONE* MDV 1MG/ML INJECTABLE, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

Batch or Lot Expiration Information

Lot# All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including
Lot# : 09262013@3

Recall Number: D-438-2014

Reason for Recall
Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.
Initiated
10-19-2013
Reported
01-22-2014
Quantity
11 mL

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
66566
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.
Specialty Medicine Compounding Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Hospitals, clinics, physicians, and patients in the Michigan area only.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-22-2014
Product Description About Product Description
Full technical description of the product.
Phenol, 6%, Injectable, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

Batch or Lot Expiration Information

Lot# All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including
Lot# : 07232013@41

Recall Number: D-410-2014

Reason for Recall
Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.
Initiated
10-19-2013
Reported
01-22-2014
Quantity
20 mL

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
66566
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.
Specialty Medicine Compounding Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Hospitals, clinics, physicians, and patients in the Michigan area only.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-22-2014
Product Description About Product Description
Full technical description of the product.
Acetylcysteine (PF) 20 % Opthalmic, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

Batch or Lot Expiration Information

Lot# All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including
Lot# : t10152013@22

Recall Number: D-458-2014

Reason for Recall
Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.
Initiated
10-19-2013
Reported
01-22-2014
Quantity
a) Injectable 800 mL; b) Topical 600 mL

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
66566
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.
Specialty Medicine Compounding Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Hospitals, clinics, physicians, and patients in the Michigan area only.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-22-2014
Product Description About Product Description
Full technical description of the product.
0.9% Sodium chloride a) DT-0.9% Sodium chloride* 100 mL Drug Study - IV 100 mL Injectable, b) DT-0.9% Sodium Chloride* 100 mL Drug Study - Topical, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

Batch or Lot Expiration Information

Lot# All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including
Lot# s: a) Injectable 09252013@8, 09302013@2, 10152013@6; b) Topical 09252013@9, 09302013@5, 10152013@8

Recall Number: D-429-2014

Reason for Recall
Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.
Initiated
10-19-2013
Reported
01-22-2014
Quantity
19200 mL

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
66566
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.
Specialty Medicine Compounding Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Hospitals, clinics, physicians, and patients in the Michigan area only.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-22-2014
Product Description About Product Description
Full technical description of the product.
Magnesium Sulfate, 1 gm/50 mL; 2 gm/50 mL, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

Batch or Lot Expiration Information

Lot# All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including
Lot# s: 07312013@41, 07312013@42, 07312013@43, 07312013@44, 07312013@45, 08012013@1, 08012013@2, 08012013@4, 08012013@6, 08012013@11, 08012013@3, 08012013@5, 08012013@7, 08012013@8, 08012013@9, 08012013@10

Recall Number: D-422-2014

Reason for Recall
Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.
Initiated
10-19-2013
Reported
01-22-2014
Quantity
38 doses

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
66566
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.
Specialty Medicine Compounding Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Hospitals, clinics, physicians, and patients in the Michigan area only.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-22-2014
Product Description About Product Description
Full technical description of the product.
Gatifloxacin, 0.2ml 0.5% (ophthalmic) (repackaged), Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

Batch or Lot Expiration Information

Lot# All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including
Lot# s: 10092013@5, 10162013@2

Recall Number: D-427-2014

Reason for Recall
Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.
Initiated
10-19-2013
Reported
01-22-2014
Quantity
53 mL

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
66566
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.
Specialty Medicine Compounding Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Hospitals, clinics, physicians, and patients in the Michigan area only.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-22-2014
Product Description About Product Description
Full technical description of the product.
HYDROXOCOBALAMIN/THIAMINE* 1 mg/100 mg/mL INJECTABLE, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

Batch or Lot Expiration Information

Lot# All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including
Lot# s: 09192013@10, 10152013@19

Recall Number: D-448-2014

Reason for Recall
Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.
Initiated
10-19-2013
Reported
01-22-2014
Quantity
15 mL

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
66566
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.
Specialty Medicine Compounding Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Hospitals, clinics, physicians, and patients in the Michigan area only.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-22-2014
Product Description About Product Description
Full technical description of the product.
QUAD MIX* IN NACL (1.8/0.2/0.02)mg/18 mcg/mL INJECTABLE, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

Batch or Lot Expiration Information

Lot# All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including
Lot# : 08262013@5

Recall Number: D-441-2014

Reason for Recall
Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.
Initiated
10-19-2013
Reported
01-22-2014
Quantity
600 mL

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
66566
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.
Specialty Medicine Compounding Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Hospitals, clinics, physicians, and patients in the Michigan area only.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-22-2014
Product Description About Product Description
Full technical description of the product.
POTASSIUM PHOSPHATE* PF 4.4 MEQ (3MM)/mL INJECTABLE, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

Batch or Lot Expiration Information

Lot# All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including
Lot# : 10032013@2, 10032013@1

Recall Number: D-457-2014

Reason for Recall
Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.
Initiated
10-19-2013
Reported
01-22-2014
Quantity
8090.8 mL

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
66566
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.
Specialty Medicine Compounding Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Hospitals, clinics, physicians, and patients in the Michigan area only.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-22-2014
Product Description About Product Description
Full technical description of the product.
Calcium Chloride* PF 500 mg/mL pref syringe, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

Batch or Lot Expiration Information

Lot# All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including
Lot# s: 09202013@1, 09202013@2, 09202013@3, 09202013@4, 09202013@5, 09202013@6, 09202013@7, 09202013@8, 10102013@7, 10102013@3, 10102013@8

Recall Number: D-460-2014

Reason for Recall
Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.
Initiated
10-19-2013
Reported
01-22-2014
Quantity
10 mL

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
66566
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.
Specialty Medicine Compounding Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Hospitals, clinics, physicians, and patients in the Michigan area only.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-22-2014
Product Description About Product Description
Full technical description of the product.
SODIUM HYDROXIDE (BAC.STATIC) 10% SOLUTION, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

Batch or Lot Expiration Information

Lot# All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including
Lot# s: 10152013@20