Ambi 40pse/400gfn recall: CGMP Deviations
AMBI 40PSE/400GFN, 100 tablet bottle, OTC, Manufactured for: AMBI Pharmaceuticals, Brooksville, FL 34604, NDC 66870-0408-01
Why was Ambi 40pse/400gfn recalled?
CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
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 # 12C007 Exp. 02/14; Lot # 12C008 Exp. 02/14.
- Product
- AMBI 40PSE/400GFN, 100 tablet bottle, OTC, Manufactured for: AMBI Pharmaceuticals, Brooksville, FL 34604, NDC 66870-0408-01
- Recalling firm
- TG United, Inc.
- Quantity
- 886 bottles - 100-count tablets
- Distribution
- FL, MS, SC, LA and TX
- Recall date
- June 12, 2013
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)