EstroPlus Maximum Strength Menopause Support Dietary Supplement in 28 count and 56 count…
Perrigo of SC recalled this product and the FDA reported the enforcement action on 15 January 2014 as Class II. The recall was initiated by the firm. Potential presence of Chloramphenicol contamination
The record
Every field below is published by the FDA in the openFDA food enforcement database. Check the FDA notice before acting on any recall: this page is a reading of the public record, not a substitute for it.
- Product
- EstroPlus Maximum Strength Menopause Support Dietary Supplement in 28 count and 56 count blister strips under the following labels - CareOne Maximum Strength Multi Symptom Menopause Formula, 28 Caplets/Dietary Supplement; Meijer Maximum Strength Estroplus, Dietary Supplement, 28 Caplets; TopCare Maximum Strength Estroplus Dietary Supplement, 28 Caplets; Sunmark Estroplus Extra Strength, Dietary Supplement, 56 Caplets; Health Mart Pharmacy Extra Strength Estroplus, 56 Caplets Dietary Supplement; Up&Up Estroplus Dietary Supplement Maximum Strength 28 Caplets; CareOne Extra Strength Estroplus 56 Caplets/Dietary Supplement; Western Family Extra Strength Estroplus 56 Caplets, Meijer Extra Strength Estroplus Dietary Supplement 56 Caplets; Publix Extra Strength Estroplus 56 Caplets, Dietary Supplement; and TopCare Extra Strength Estroplus Dietary Supplement 56 Caplets.
- Reason for recall
- Potential presence of Chloramphenicol contamination
- Recalling firm
- Perrigo of SC
- Firm location
- Greenville, South Carolina, United States
- Classification
- Class II
- Status
- Terminated
- Recall number
- F-1384-2014
- Quantity
- 68,534 (units/eaches)
- Distribution
- FL, IL, MI, MN, OR, PA & TX
- Initiated
- 25 November 2013
- Reported by FDA
- 15 January 2014
- Terminated
- 10 November 2014
- Firm notified by
- Letter
- Product codes
- 3FN0981 (Exp 04/15), 3FN1338 (Exp 04/15), 3FN1116 (Exp 04/15), 3EN1050 (Exp 04/15), 3JN1230 (Exp 04/15), 3KN1691 (Exp 05/15), 3KN1207 (Exp. 05/15), 3JN1013 (05/15), 3JN1077 (Exp 05/15), 3HN1293 (Exp 05/15), 1KN1496 (Exp 05/14), 1JN1234 (Exp 05/14), 1KN1775 (Exp. 05/14), 1LN1254 (Exp 05/14), 1LN1867 (Exp 05/14), 1MN1647 (Exp 05/14), 2AN1562 (Exp 10/14), 2AN1595 (Exp 10/14), 2BN2120 (Exp 01/15), 2DN1514 (Exp 01/15), 2DN1515 (Exp 10/14), 2DN1608 (Exp 05/14), 2DN1997 (Exp 01/15), 2EN2099 (Exp. 01/15), 2FN1524 (Exp 03/15), 2FN1923 (Exp 03/15), 2FN1939 (Exp 01/15), 2GN1806 (Exp 03/15), 2HN1412 (Exp 03/15), 2HN1496 (Exp 03/15), 2JN1383 (Exp 03/15), 2MN1156 (Exp 03/15), 3AN1835 (Exp 03/15), 3BN1683 (Exp 03/15), 3DN1482 (Exp 03/15), 3FN1132 (Exp 03/15)
Reading this record
Five things about this record are not in the record itself, and each one changes how it should be read.
- Class II means the FDA judged a remote probability of serious harm, or a probability of temporary or medically reversible harm. The class is assigned by an agency health hazard evaluation under 21 CFR 7.41, not by the firm.
- The firm started this recall itself. Most FDA food recalls are voluntary, and a recall is a food safety plan working rather than failing. The circumstances in which the agency asks for one instead are set out in 21 CFR 7.45.
- This record is the only one the FDA opened for its recall event, so it covers a single product code.
- The recall ran for 11 months, from 25 November 2013 to termination on 10 November 2014. Termination means the agency judged that all reasonable effort had been made, under 21 CFR 7.55, and it says nothing about whether product remained in circulation.
- The distribution pattern names 5 states, and the FDA published the enforcement report 7 weeks after the firm began the recall.
- Recalls of a dietary supplement run a median of 15 months, so this one was about typical for its category. Dietary supplements are regulated under their own good manufacturing practice rule, 21 CFR part 111, and they are the only food category where the dominant recall reason is an ingredient that was never declared because it is a pharmaceutical.
Named in the distribution pattern: Florida, Illinois, Michigan, Minnesota, Oregon. Those pages count recalls by where the RECALLING FIRM sits, which is a different question from where this product went.
Filed under dietary supplements. A product can sit in more than one.
Other dietary supplements recalls
These are the closest records in the corpus: the same kind of food. Unlike the firm’s own records below, they come from different companies, which is what makes them a pattern rather than a history.
All 2014 recalls · All FDA food recall data
Behind every recall is a clause somebody has to produce evidence for at their next audit. Krolda maps supplier documents to the clause they satisfy in FSSC 22000, IFS Food and 21 CFR 117, and routes the corrective action when the evidence is missing.
Early accessRecall records come from the openFDA food enforcement API, published by the U.S. Food and Drug Administration in the public domain. Krolda adds the hazard classification and the clause mapping; neither is an FDA determination. Always check the FDA notice before acting on a recall.