Doxycycline Hyclate USP recall: Labeling Error
Doxycycline Hyclate USP, active pharmaceutical ingredient, a) 25 g packaged in a 500 cc container (NDC: 58597-8082-4), b) 100 g packaged in 16 oz container (NDC: 58597-8082-6), c) 500 g packaged in a 2500 cc container (NDC: 58597-8082-7) and a 1,000 g packaged in 1 gallon container (NDC: 58597-8082-8). For Prescription Compounding RX Only. Packed under cGMP conditions by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
Why was Doxycycline Hyclate USP recalled?
Labeling: Not Elsewhere Classified. Manufacturer and product were discovered to be on FDA Import Alert 66-66 for misbranding of active pharmaceutical ingredient.
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: 082815-1, EXP 06/04/2019
- Product
- Doxycycline Hyclate USP, active pharmaceutical ingredient, a) 25 g packaged in a 500 cc container (NDC: 58597-8082-4), b) 100 g packaged in 16 oz container (NDC: 58597-8082-6), c) 500 g packaged in a 2500 cc container (NDC: 58597-8082-7) and a 1,000 g packaged in 1 gallon container (NDC: 58597-8082-8). For Prescription Compounding RX Only. Packed under cGMP conditions by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
- Recalling firm
- American Pharmaceutical Ingredients LLC
- Quantity
- 23.5kg
- Distribution
- Nationwide in the US
- Recall date
- July 5, 2017
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)