NRAC Issue #1641	ADDENDUM		July 31, 2007		

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PRODUCT       a) Gebauer's Pain Ease Mist Spray - Topical Anesthetic Skin
              Refrigerant -is a vapocoolant (skin refrigerant) packed in an
              aerosol container. Rx only  103.5ml (3.5 fl. oz.) can
              (Product Number 0386-0008-02)
RECALL NUMBER # Z-1057-2007
PRODUCT       b) Gebauer's Spray and Stretch Fine - Stream Topical Anesthetic
              Skin Refrigerant -is intended for topical application to skin
              for use in controlling pain associated with injections and the
              temporary relief of minor sports injuries. Rx only  3.5 fl. oz.
              (103.5ml) can. Product Number 0386-0004-04
RECALL NUMBER # Z-1058-2007
PRODUCT       c) Gebauer's Instant Ice Mist - is used like ice for the
              temporary relief and reduction of minor pain and swelling from
              sprains, strains, bruising, contusions or minor sports injuries.
              3.5 fl. oz. (103.5ml) can. (Product Number: 0386-0010-05)
RECALL NUMBER # Z-1059-2007
PRODUCT       d) Gebauer's Instant Ice Medium Stream for temporary relief and
              reduction of minor pain and swelling from sprains, strains,
              bruising, contusions or minor sports injuries.-3.5 fl. oz.
              (103.5ml) can. (Product Number-0386-0010-01)
RECALL NUMBER # Z-1060-2007
PRODUCT       e) Pain Ease Medium Stream - Topical Anesthetic Skin Refrigerant
              is a vapocoolant (skin refrigerant) packed in an aerosol
              container. Rx only. 103.5ml (3.5 fl. oz.) can. (Product
              Number-0386-0008-03)
RECALL NUMBER # Z-1061-2007
PRODUCT       f) Gebauer's Pain Ease Sample Spray - Topical Anesthetic Skin
              Refrigerant is a vapocoolant (skin refrigerant) packed in an
              aerosol container, Rx only, 30 mL(1.0 fl. oz.) can.
              (Product Number-0386-0008-01)
RECALL NUMBER # Z-1062-2007
CODE          a) Lot numbers: 4256 expires 08-08; 4257 expires 10-08 and 4258
              expires 12/08;
              b) Lot Numbers: 8019 expires 08-08; 8020 expires 09-08; 8021
              expires 10-08 and 8022 expires 12/08;
              c) Lot number 4009 expires 08-08; 4010 expires 12/08;
              d) Lot numbers6015 expires 10-08 and 6016 expires 11/08;
              e) Lot numbers 6257 expires 08-08; 6258 expires 09-08 and 6259
              expires 10/08; 6260 expires 11-08 and 6261 expires 12/08;
              f) Lot number 9253 expires 11-08
MANUFACTURED & RECALLED BY  Gebauer Company, Cleveland, OH
QUANTITY      41,499 aerosol cans
DISTRIBUTION  Nationwide
REASON        Mold contamination

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PRODUCT       a) Fougera Mupirocin Ointment USP, 2%, Net. Wt. 22 grams tubes
              (NDC 0168-0352-22)
              b) Foilpacs (NDC 0168-0352-09), Net Wt. 72 x 0.9 g (1/32 Oz), Rx
              only
RECALL NUMBER # D-844-2007
CODE          a) Lots: T416 (exp. 8/07), X579 (exp. 7/08), X580 (exp. 11/08),
              U221(exp. 12/07),  U323 (exp. 12/07);
              b) Lots: T298 (exp. 8/07), T299 (exp. 8/07), U010 (exp. 11/07),
              U011 (exp. 11/07), U239 (exp. 12/07), U345 (exp. 1/08)
MANUFACTURER  Altana Inc., Hicksville NY
RECALLED BY   Altana Inc., Melville, NY
QUANTITY      9 g foil packs: 59,832 units; 22 g tubes: 173,805 units
DISTRIBUTION  Nationwide, PR, and Bermuda
REASON        The product is subpotent.

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PRODUCT       a) ShiR Fresh Anticavity Fluoride Toothpaste, Mint Flavor, Net
              Weight 9 oz., labeled ingredients include: Sodium
              Monofluorophosphate 0.70%, Glycerin, Sorbitol. Made in China
RECALL NUMBER # D-845-2007
PRODUCT       b) ShiR Fresh Anticavity Fluoride Toothpaste, Ice ShiR Mint
              Flavor, Net Weight 6.4 oz., labeled ingredients include: Sodium
              Monofluorophosphate 0.70%, Glycerin, Sorbitol. Made in China 
RECALL NUMBER # D-846-2007
PRODUCT       c) ShiR Fresh Anticavity Fluoride Toothpaste, Cool ShiR Mint
              flavor, Kids Mint, Net Weight 6.4 oz., labeled ingredients
              include: Sodium Monofluorophosphate 0.70%, Glycerin, Sorbitol.
              Made in China
RECALL NUMBER # D-847-2007
CODE          a) Lots: 777A, 777B, 777C, 777D;
              b) Lot: 2471A;
              c) Lot: 2471B
MANUFACTURED & RECALLED BY     Gold City Enterprise, LLC, Aventura, FL
QUANTITY      155,880 tubes
DISTRIBUTION  FL
REASON        Toothpaste from China contains the poisonous chemical diethylene
              glycol (DEG).

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