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SafetyAlerts
January 17, 2002

Perrigo Has Recalled Infants' Simethicone Drops

Allegan, MI (SafetyAlerts) - The Food and Drug Administration (FDA) said that Perrigo has recalled Infants' Simethicone Drops, Simethicone, 20 mg in each 0.3 mL, 1 fluid ounce(30mL) bottles. This product was distributed under 52 brand labels.

PRODUCT
Infants' Simethicone Drops, Simethicone, 20 mg in each 0.3 mL, 1 fluid ounce(30mL) bottles. This product was distributed under 52 brand labels, Recall # D-068-2.

1) Guardian brand Infant's Wind Relief With Simethicone, NDC: N/A.
2) Albertson's brand, NDC: 41163-119-10. Discontinued.
3) Sav-on Osco by Albertson's brand Infants' Simethicone Drops,  NDC: 41163-119-10.
4) Sav-on Osco by Albertson's brand Infants' Simethicone Drops,  Non-Staining Formula, NDC: 41163-882-10.
5) American Fare brand Infants' Gas Symptom Relief Simethicone Drops, NDC: 49738-119-10.
6) Ameripharm brand Infants' Baby Gaz Simethicone Anti-Gas Drops, NDC: N/A.
7) Brite-Life brand Infants' Gas Relief Drops Simethicone
Anti-Gas, NDC: 24385-785-30.
7) Dominick's brand Infants' Simethicone Drops,
NDC:38694-119-10.
9) Drug Emporium brand Infants' Simethicone Drops, NDC: 62865-119-10.
10) Elect Health brand Infants' Gas Relief Drops Simethicone, Non-Staining Formula, NDC: 37012-882-10.
11) Equate brand Infants' Gas Relief Drops Simethicone, Non-Staining Formula, NDC: 0113-1882-10.
12) Finast brand Infants' Gas Relief Drops Simethicone, Non-Staining Formula, NDC: 41520-882-10.
13) Food Lion brand Infants' Simethicone Drops, NDC:55316-119-10.
14) Full Value brand NDC: 52297-299-10.
15) Giant Eagle brand Infants' Gas Relief Drops Simethicone, NDC: 56194-119-10.
16) Good Neighbor Pharmacy brand Infants' Gas Relief Drops, Simethicone, NDC: 24385-785-30.
17) Good Sense brand Infants' Simethicone Drops, Perrigo. NDC: 0113-0119-10.
18) Good Sense brand Infants' Simethicone Drops, Non-Staining Formula, Perrigo. NDC: 0113-0882-10.
19) H.E.B. Pharmacy brand Infants' Simethicone Drops, NDC: 37808-119-10.
20) Health Mart Pharmacies brand Simethicone Gas Relief Infants' Drops, NDC: 52297-664-10.
21) Kaiser Permanente brand Infants' Simethicone Drops, Kaiser Foundation Hospitals, Livermore, CA. NDC: 0179-0119-10.
22) Kn'K Preferred brand Infants' Simethicone Drops, Dist. by Kash n' Karry, Tampa, FL. NDC: 46279-119-10.
23) Kerr Drug brand Infants' Simethicone Drops, NDC: 55166-119-10.
24) Kroger brand Infants' Simethicone Drops, Non-Staining Formula, NDC: 30142-882-10.
25) Leader brand Infants' Simethicone Drops, Dist. by Cardinal Health, Inc., Dublin, OH. NDC: 37205-119-10.
26) Longs brand Infants' Simethicone Drops, Dist. by Longs Drug Stores, Walnut Creek, CA. NDC: 12333-9972-1.
27) Longs brand Infants' Simethicone Drops Non-Staining Formula, NDC: 12333-9879-1.
28) Marquee brand Infants' Simethicone Drops, NDC: 11205-119-10.
29) May's Drug brand Infants' Simethicone Drops Non-Staining Formula, NDC: 56017-882-10.
30) Meijer brand Infants' Simethicone Drops Non-Staining Formula, NDC: 41250-882-10.
31) Osco brand NDC: 12810-119-10. Discontinued.
32) Osco brand NDC: 12810-882-10. Discontinued.
33) Perfect Choice brand Infants' Simethicone Drops, NDC: 41226- 119-10.
34) Perfect Choice brand Infants' Simethicone Drops Non-Staining Formula, Cincinnati, OH. NDC: 41226-882-10.
35) Phar Mor brand Infants' Simethicone Drops, NDC: 60362-119-10.
36) Phar Mor brand Infants' Simethicone Drops Non-Staining  Formula, NDC: 60362-882-10.
37) Safeway brand Infants' Simethicone Drops, NDC: 21130-119-10.
38) Sav-On brand NDC: 37097-119-10. Discontinued.
39) Sav-On brand NDC: 37097-882-10. Discontinued.
40) Shop Rite brand Infants' Simethicone Drops, NDC: 41190-119-10.
41) Shopko brand NDC: 37012-882-65. Discontinued.
42) Stater Bros. Markets brand Infants' Simethicone Drops,  NDC: 38985-119-10.
43) Stop & Shop brand Infants' Gas Relief Drops Non-Staining Formula, NDC: 21120-882-10.
44) Swan brand Infants' Simethicone Drops, Perrigo.
NDC: 0113-0119-10.
45) Target brand Infants' Gas Relief Non-Staining Formula, NDC: 11673-882-10.
46) Today's Health brand Infants' Simethicone Drops,
NDC: 38309-119-10.
47) Top Care Infants' Simethicone Drops, NDC: 36800-119-10.
48) Valu Rite brand Simethicone Gas Relief Infants' Drops, NDC: 49348-577-34.
49) Valu Rite brand Simethicone Gas Relief Infants' Drops
Non-Staining Formula, NDC: 49348-376-27.
50) Vons brand Infants' Simethicone Drops, NDC: 58828-119-10.
51) Walgreens brand Infants' Gas Relief Drops,
NDC: 0363-0119-10.
52) Walgreens brand Infants' Gas Relief Drops Non-Staining Formula, NDC: 0363-0882-10.
53) Western Family brand Simethicone Infants' Gas Relief Drops, NDC: 55312-119-10.
54) Medic brand Infants' Simethicone Drops, NDC: 56039-119-10.

CODE
All lots within expiry.

RECALLING FIRM/MANUFACTURER
Perrigo, Allegan, MI, by letter on 11/28/01. Firm initiated recall is ongoing.

REASON
Subpotent for simethicone.

VOLUME OF PRODUCT IN COMMERCE
234,473 bottles

DISTRIBUTION
Nationwide, Vietnam and the Philippines
.

 
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The information contained herein has been obtained from sources that the Company believes to be reliable, however, the Company has not independently verified or confirmed the information and the recipient acknowledges that no representations or warranties are being made in connection with the use of the information.