| FDA Recalls |
10-Jun-09 |
| CLASS I |
| Bupivacaine HCl and HYDROmorphone HCl |
| (a) 0.25%, 200 mL total volume, in a 250 mL intravia bag, in sodium chloride 0.9%, epidural use only, Rx only, service code 2K8243, NDC 61553-243-37; (b) 0.5 mg per mL (25 mg per 50 mL), 50 mL total volume in a 60cc monoject syringe in sodium chloride 0.9%, IV use only, Rx only, service code 2K8633, NDC 61553-633-75. |
| Manufacturer: |
PharMEDium Services, LLC, Cleveland, MS. |
| Recalled by: |
Manufacturer, by telephone on March 31, 2009 and April 3, 2009 and by letters on April 17, 2009 and April 27, 2009. Firm-initiated recall is ongoing. |
| Distribution: |
TN, AR, NY, OR, WI, ID; 293 units. |
| Reason: |
Mislabeling. |
| Recall numbers: |
D-658/659-2009. |
| CLASS II |
| 6 INFeD (IRON DEXTRAN Injection) |
| 100 mg elemental iron/2 mL, 50 mg/mL, for intramuscular or intravenous use, 10x2 mL, boxes of 10 vials, Rx only, NDC 52544-0931-02. |
| Manufacturer: |
Watson Labs, Inc., Corona, CA. |
| Recalled by: |
Manufacturer, by letters on March 16, 2009 and April 2, 2009. Firm-initiated recall is ongoing. |
| Distribution: |
Nationwide, Australia and New Zealand; 125,257 boxes (10x2mL vials per box). |
| Reason: |
Watson initiated this recall as a precautionary measure due to remaining stock of these lots having a potential risk of formation of precipitate in the injection solution, therefore product which may contain particulate matter may represent a potential health hazard when administered intravenously. |
| Recall number: |
D-655-2009. |
| CLASS III |
| Muse (alprostadil) Urethral Suppository |
| (a) Transurethral system, 125 mcg, refrigerate immediately, Rx only, NDC 624541-110-06 - carton of 6 pouches, NDC 62541-110-01 - individual pouch; (b) transurethral system, 250 mcg, refrigerate immediately, Rx only, NDC 624541-120-06 - carton of 6 pouches, NDC 62541-120-01 - individual pouch. |
| Manufacturer: |
Vivus, Inc., Lakewood, NJ. |
| Recalled by: |
Vivus, Inc., Mountain View, CA, by letters on May 20, 2009. Firm-initiated recall is ongoing. |
| Distribution: |
Nationwide; 61,152 suppositories. |
| Reason: |
Out of Specification: Expiration date not assured at 24 months for known total impurity meeting <5.0% molar. |
| Recall numbers: |
D-656/657-2009. |
| EDITORS' NOTE: Tabulation prepared from information provided by FDA. The agency has three classes of recalls. Class I - violative product poses reasonable probability of serious adverse health consequences or death; Class II - violative product may cause temporary or medically reversible adverse health consequences; probability of serious consequences remote; Class III - violative product not likely to cause adverse health consequences. Editors of "The Pink Sheet" appreciate hearing from any company that would like to provide additional information on any recall listed in a weekly tabulation. |