Prefera OB One Gel Capsules — Class II drug recall D-1418-2012
Terminated recall by Meda Pharmaceuticals Inc., reported 2012-07-25, distributed nationwide. Labeling: Presence of Undeclared Color Additive; The product is being recalled because several inactive ingred
| Recall number | D-1418-2012 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Meda Pharmaceuticals Inc., Somerset, NJ, United States |
| Recall initiated | 2011-10-17 |
| Classified | 2012-07-13 |
| Reported by FDA | 2012-07-25 |
| Terminated | 2017-02-08 |
| Distributed | Nationwide (US) |
| Reason classes | undeclared allergen, labeling |
| NDC | 68220-0086-30 |
| Lot numbers | 000001, 000002, 249814, 249816, 255345, 260393, 261827, 4/30/20012, 500007, 50004, 50005, 9/30/20012 |
| Expiration dates | 2011-11-30, 2012-05-31, 2012-08-31, 2012-11-30, 2012-12-31 |
Product
Prefera OB One Gel Capsules, 30 softgels, Rx Only, Manufactured by: IVC industries, Inc. Irving ton, NJ 07111, For: Alaven Pharmaceutical LLC Marietta, GA 30062, NDC 68220-086-30
Reason for recall
Labeling: Presence of Undeclared Color Additive; The product is being recalled because several inactive ingredients were not included in the labeling for this product: Undeclared D&C Red #33, FD&C Blue #1, Titanium Dioxide Suspension, Purified Water USP.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-1418-2012. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.