Anu-Med brand of Hemorrhoidal Suppositories recall: CGMP Deviations
Anu-Med brand of Hemorrhoidal Suppositories (Phenylephrine HCl 0.25%; Hard Fat 88.7%), 12 suppositories per carton, NDC: 0904-7688-22, Distributed by Major Pharmaceuticals, Livonia MI 48152.
Why was Anu-Med brand of Hemorrhoidal Suppositories recalled?
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot #s: 17L008, Exp. 05/2019; 17M011; 17M037, Exp. 06/2019; 18A015, Exp. 07/2019; 18B012; 18B023, Exp. 08/2019; 18K023; 18K029, Exp. 04/2020; 18L014, Exp. 05/2020; 19A001, Exp. 06/2020.
- Product
- Anu-Med brand of Hemorrhoidal Suppositories (Phenylephrine HCl 0.25%; Hard Fat 88.7%), 12 suppositories per carton, NDC: 0904-7688-22, Distributed by Major Pharmaceuticals, Livonia MI 48152.
- Recalling firm
- Torrent Pharma Inc
- Quantity
- 177,408 bottles
- Distribution
- Product was distributed to 9 distributors, direct accounts and relabelers who may have further distributed the product throughout the United States.
- Recall date
- June 19, 2019
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)