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Recall Alert Information

FDADocs 5/9/2008 | 0 (0) | 8 | 0 | 0 | English

Attachment A – Recall Alert Information Submit the information listed below to the CRU and OE/DCMO via RES: • Product(s) Description • Codes • Recalling Firm • Short Reason for Recall • District  ... more>>

Requested recall shellhigh

GovernmentDocs 5/5/2008 | 0 (0) | 7 | 0 | 0 | English

07083 Dear Dr. Gabbay:- 2 2007FDA requests that Shelhigh, Inc. initiate an immediate recall of all... classifying this action as an FDA-Requested Class I recall and recommend that you perform level A  ... more>>

Recommendation for Recall Classification

FDADocs 5/9/2008 | 0 (0) | 7 | 0 | 0 | English

) Recall Strategy field - If the firm was advised of FDA findings and the problem was discussed with them, report its reactions and recall plans in detail. Similarly, if the firm advised FDA of the problem  ... more>>

Hearltland recall notice

GovernmentDocs 5/4/2008 | 0 (0) | 8 | 0 | 0 | English

URGENT: DRUG RECALLHRS Lot All lot numbers beginning with the letter “K” Example K... number beginning with “K”. The specific products and lot numbers subject to this recall can be  ... more>>

Baxter

GovernmentDocs 5/4/2008 | 0 (0) | 10 | 0 | 0 | English

Baxter Hea/Ihcare Corporation Route 120 & Wdsoo Road Round Lake. IIIirK)is 60073-0490847.546.6311September 28, 2005Re:Proper Routing of Blood Tubing Set for MERIDIAN ...  ... more>>

Recommendation for Recall Classification and Termination

FDADocs 5/9/2008 | 0 (0) | 8 | 0 | 0 | English

Attachment B1 - Recommendation for Recall Classification and Termination Note: Under RES, this information will be a continuation of the electronic recall record and many of these fields will be pre  ... more>>

Methods for Conducting Recall Effectiveness Checks

FDADocs 5/9/2008 | 0 (0) | 7 | 0 | 0 | English

section 7.42(b)(3) of the FDA recall guidelines, the following may bee used as a guide on how to use...Attachment H –Methods for Conducting Recall Effectiveness Checks INTRODUCTION In the Federal  ... more>>

Recall Termination or Recommendation for Termination

FDADocs 5/9/2008 | 0 (0) | 7 | 0 | 0 | English

Attachment C - Recall Termination or Recommendation for Termination A Recall Termination (Summary) or Termination Recommendation must be prepared and submitted for those recall actions not terminated  ... more>>

Recall information from Baxter

GovernmentDocs 5/4/2008 | 0 (0) | 6 | 0 | 0 | English

Baxter decided not to recall all Baxter heparin vial products at that time. The FDA has now concluded...Baxter to Proceed with Recall of Remaining Heparin Sodium Vial ProductsBaxter Worldwide  ... more>>

Recall information from B Braun

GovernmentDocs 5/4/2008 | 0 (0) | 5 | 0 | 0 | English

’S SUPPLIER RECALL OF HEPARIN API PROMPTS VOLUNTARY RECALL OF HEPARIN SOLUTIONS Scientific Protein..., Scientific Protein Laboratories LLC (SPL) of a nationwide recall of Heparin Sodium USP active  ... more>>


   
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