ZINC GLUCONATE, Tablet, 50 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00904319160. Class II

Reason: Labeling: Label Mixup; ZINC GLUCONATE, Tablet, 50 mg may be potentially mis-labeled as ASCORBIC ACID, Chew Tablet, 500 mg, NDC 00904052660, Pedigree: AD60240_54, EXP: 5/22/2014 and ASCORBIC ACID, Chew Tablet, 250 mg, NDC 00904052260, Pedigree: W003027, EXP: 6/12/2014.

Aidapak Services, LLC 20130702 Terminated
Distributed: Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
NorthStar Arthritis Relief Cream. Net Wt. 2 oz tube, OTC, Manufactured for and Distributed by NewMarket Health Products, LLC. 702 Cathedral St. Baltimore, MD 21201 Class II

Reason: Microbial Contamination of Non-Sterile Products: Arthritis Relief Cream failed microbiological specifications.

Mariposa Labs, LLC 20121129 Terminated
Distributed: One consignee who in turn sent it to one consignee
Aminosyn II, 10%, Sulfite-Free Amino Acid Injection, 500 mL container, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-4164-03, UPC (01) 0 030409 416403 8. Class I

Reason: Presence of Particulate Matter: Confirmed customer complaint of particulate matter, identified as a human hair, visible in the injection port and primary container.

Hospira Inc. 20130830 Terminated
Distributed: Nationwide
SODIUM HYDROXIDE (BAC.STATIC) 10% SOLUTION, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178 Class II

Reason: 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.

Specialty Medicine Compounding Pharmacy 20131019 Terminated
Distributed: Hospitals, clinics, physicians, and patients in the Michigan area only.
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 Class II

Reason: 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.

Specialty Medicine Compounding Pharmacy 20131019 Terminated
Distributed: Hospitals, clinics, physicians, and patients in the Michigan area only.
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 Class II

Reason: 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.

Specialty Medicine Compounding Pharmacy 20131019 Terminated
Distributed: Hospitals, clinics, physicians, and patients in the Michigan area only.
Calcium Chloride* PF 500 mg/mL pref syringe, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178 Class II

Reason: 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.

Specialty Medicine Compounding Pharmacy 20131019 Terminated
Distributed: Hospitals, clinics, physicians, and patients in the Michigan area only.
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 Class II

Reason: 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.

Specialty Medicine Compounding Pharmacy 20131019 Terminated
Distributed: Hospitals, clinics, physicians, and patients in the Michigan area only.
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 Class II

Reason: 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.

Specialty Medicine Compounding Pharmacy 20131019 Terminated
Distributed: Hospitals, clinics, physicians, and patients in the Michigan area only.
VANCOMYCIN HCL 10 mg/mL OPHTHALMIC SOLUTION, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178 Class II

Reason: 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.

Specialty Medicine Compounding Pharmacy 20131019 Terminated
Distributed: Hospitals, clinics, physicians, and patients in the Michigan area only.
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