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.