Drug recall: Best Choice Health Care, Psyllium Fiber Supplement, 100% natural Psyllium Fiber Laxative, 100 capsules per bottle…
Class II FDA enforcement event 63384. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
Microbial Contamination of Non-Sterile Products: Product is being recalled due to possible microbial contamination by C. difficile discovered in the raw material.
Class II, in the words of FDA
a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Raritan Pharmaceuticals, Inc. started this drug recall on 4 Sep 2012. The firm address in the FDA record is in East Brunswick, NJ. FDA put the recall in Class II. FDA event 63384 has 12 product records. The first FDA enforcement report date is 31 Oct 2012. The record gives the status Terminated, with the termination date 7 Oct 2014.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
Nationwide
Recalling firm
Raritan Pharmaceuticals, Inc., East Brunswick, NJ.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
12 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| D-021-2013 | Best Choice Health Care, Psyllium Fiber Supplement, 100% natural Psyllium Fiber Laxative, 100 capsules per bottle, Proudly Distributed by: Valu Merchandisers, Co., Kansas City, KS 06106, UPC 0-70038-63439-3 | 2160 bottles | Class II | Terminated | 31 Oct 2012 |
| D-022-2013 | CVS Pharmacy Fiber Capsules for Regularity, Dietary Fiber Supplement, 100 Capsules per bottle, Distributed by: CVS Pharmacy, Inc., Woonsocket, RI 02895 www.cvs.com UPC 0-50428-07739-9 | 16,848 bottles | Class II | Terminated | 31 Oct 2012 |
| D-023-2013 | Equate Fiber Therapy, 100% Natural Psyllium Husk Fiber, Fiber Laxative/Fiber Supplement, 160 capsules per bottle, Distributed by: Wal-Mart Stores, Inc., Bentonville, AR 72716, NDC 68163-119-60, UPC 6-81131-77922-7. | 183,141 bottles | Class II | Terminated | 31 Oct 2012 |
| D-024-2013 | Leader Fiber Capsules, 100% Natural Psyllium Fiber Laxative, Dietary Fiber Supplement, Relieves Constipation, Restores Regularity, 100 capsules per bottle, Distributed by: Cardinal Health, Dublin, OH 43017 www.myleader.com, NDC 37205-372-78, UPC 0-96295-11222-1. | 2,988 bottles | Class II | Terminated | 31 Oct 2012 |
| D-025-2013 | Up&Up Psyllium Fiber Supplement, 100% natural psyllium husk, Fiber Therapy for Regularity/Fiber Supplement, 160 capsules per bottle, Distributed by: Target Corp., Minneapolis, MN 55403, Made in USA, NDC 11673-059-87, UPC 3-68163-11926-8. | 48,120 bottles | Class II | Terminated | 31 Oct 2012 |
| D-026-2013 | Wal-Mucil 100% Natural Fiber, 100% Natural Psyllium Seed Husk, Fiber Laxative/Supplement, a)160 capsules per bottle (item #503663), and b) 320 capsules per bottle (Item #586143), Distributed by: Walgreen Co., 200 Wilmot Road, Deerfield, IL 60015-4616, www.walgreens.com, a) UPC 3-11917-08151-9, b) UPC 3-11917-07658-4 | 56,808 bottles | Class II | Terminated | 31 Oct 2012 |
| D-027-2013 | Wal-Mucil Plus Calcium Fiber Capsules,100% Natural Fiber, 100% Natural Psyllium Seed Husk, Calcium/Dietary Fiber Supplement, 240 Capsules per bottle, Distributed by: Walgreen Co., 200 Wilmot Road, Deerfield, IL 60015-4616 www.walgreens.com, NDC 0363-0128-24, UPC 3-11917-07656-0. | 7,608 bottles | Class II | Terminated | 31 Oct 2012 |
| D-028-2013 | Berkley & Jensen Fiber Capsules, Fiber Laxative/Fiber Supplement, 100% Natural Psyllium Fiber, 400 capsules per bottle, Distributed by: BJWC, 25 Research Drive, Westborough, MA 01581, Made in USA, UPC 4-00016-27053-2. | 3,552 bottles | Class II | Terminated | 31 Oct 2012 |
| D-029-2013 | Simply Right Healthcare Fiber Capsules, 100% Natural Psyllium Fiber, Fiber Supplement, Fiber Laxative for Regularity, 400 capsules per bottle, Distributed by: SAM'S West, Inc., Bentonville, AR 72716, UPC 0-78742-00524-9. | 46,104 bottles | Class II | Terminated | 31 Oct 2012 |
| D-030-2013 | Premier Value Fiber Capsules, Fiber Capsules, 100% Natural Psyllium Fiber, Relieves Constipation, Restores Regularity, 160 Capsules per bottle, Distributed by: Chain Drug Consortium, LLC, Boca Raton, FL 33431, UPC0-40986-01703-2 | 1,440 bottles | Class II | Terminated | 31 Oct 2012 |
| D-031-2013 | Premier Value Fiber Plus Calcium Supplement Capsules, 120 capsules per bottle, Distributed by: Chain Drug Consortium, LLC, Boca Raton, FL, UPC 8-40986-01987-6 | 96 bottles | Class II | Terminated | 31 Oct 2012 |
| D-032-2013 | DRxChoice Fiber Capsules, 25 capsules per bottle, Psyllium Husk Fiber, Mfg. by Raritan Pharmaceuticals, East Brunswick, NJ, UPC 3-68163-11925-1. | 17,136 bottles | Class II | Terminated | 31 Oct 2012 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class II: The middle of the three FDA recall classes.
The event in context
- Drug events that started in 2012
- 209
- Share of these events in Class II
- 56%
- Product records in this event
- 12Median of the firm: 12
- Events of the firm on the register
- 2
Other events of the firm
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 18 Nov 2016 | CVS Health Homeopathic Infants Teething Tablets 135 count bottle Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woons | Drug | Class II | 3 |
Official channels
- FDA enforcement report D-021-2013The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
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Cite this page
Recall Register. FDA enforcement event 63384. https://recallregister.com/fda/ii/63384/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA drug enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
Nationwide
- What quantity of product is in FDA event 63384?
- The event has 12 product records. The first record gives this quantity:
2160 bottles
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many drug recalls of 2012 have the same class?
- 56% of the 209 drug events that started in 2012 are in Class II.