Why it was recalled
Failed Stability Specifications: Product exceeds compendia and firm's specifications for iron content.
Product description
Potassium Phosphate, Monobasic, Crystal, NF, Multi-Compendial, Bulk Pharmaceutical Chemical, packaged in a) 500G glass bottles, product number 3248-01, NDC 10106-3248-1; b) 2.5KG glass bottles, product number 3248-05, NDC 10106-3248-2; c) 12KG pails, product number 3248-07, NDC 10106-3248-3; d) 1KT bottles and drums, product number 3248-X2; e) 1KT bottles and drums, product number 3248-X3; f) 12KG pails, product number 7390-19; Avantor Performance Materials, LLC, 100 Matsonford, Road, Suite 200, Radnor, PA 19087.
Lot numbers, UPCs & expiration codes
Batch: a) 0000226380; b) 0000224662, 0000224663, and 0000227641; c) 0000227640; d) 0000224809; e) 0000224818 and 0000225900; f) 0000224661; Retest Date 12/7/2023
Where it was sold
Nationwide in the USA, Canada, India, and Singapore
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0575-2020
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Oct 30, 2019
- FDA report date
- Dec 4, 2019
- Quantity
- a) 36 bottles; b) 85 bottles; c) 43 pails; d) 28 bottles and drums; e) 100 bottles and drums; f) 4 pails
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Avantor Performance Materials Inc
Original FDA data
Every field from FDA enforcement report D-0575-2020, exactly as published.
Show all FDA fields
- City
- Paris
- State
- KY
- Status
- Terminated
- Country
- United States
- Event ID
- 84188
- Address
- 7001 Martin Luther King Jr Blvd
- Code information
- Batch: a) 0000226380; b) 0000224662, 0000224663, and 0000227641; c) 0000227640; d) 0000224809; e) 0000224818 and 0000225900; f) 0000224661; Retest Date 12/7/2023
- Postal code
- 40361-2147
- Report date
- Dec 4, 2019
- Product type
- Drugs
- Recall number
- D-0575-2020
- Classification
- Class II
- Recalling firm
- Avantor Performance Materials Inc
- Product quantity
- a) 36 bottles; b) 85 bottles; c) 43 pails; d) 28 bottles and drums; e) 100 bottles and drums; f) 4 pails
- Termination date
- Jul 16, 2023
- Reason for recall
- Failed Stability Specifications: Product exceeds compendia and firm's specifications for iron content.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Potassium Phosphate, Monobasic, Crystal, NF, Multi-Compendial, Bulk Pharmaceutical Chemical, packaged in a) 500G glass bottles, product number 3248-01, NDC 10106-3248-1; b) 2.5KG glass bottles, product number 3248-05, NDC 10106-3248-2; c) 12KG pails, product number 3248-07, NDC 10106-3248-3; d) 1KT bottles and drums, product number 3248-X2; e) 1KT bottles and drums, product number 3248-X3; f) 12KG pails, product number 7390-19; Avantor Performance Materials, LLC, 100 Matsonford, Road, Suite 200, Radnor, PA 19087.
- Distribution pattern
- Nationwide in the USA, Canada, India, and Singapore
- Recall initiation date
- Oct 30, 2019
- Initial firm notification
- Center classification date
- Dec 6, 2019