🔍 RecallPedia

Progesterone USP (Micronized) (Yam) for prescription compounding, packaged in a) 1g (NDC 58597-8471-1); b) 10g (NDC 58597-8471-3); c) 25g (NDC 58597-8471-4); d) 100g (NDC 58597-8471-6); e) 500g (NDC 58597-8471-7); f) 1000g (NDC 58597-8471-8); g) 5000g (NDC 58597-8471-9), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327

Class I - Dangerous
💊 Drugs Recalled: February 9, 2018 American Pharmaceutical Ingredients Prescription Drugs Nationwide

What Should You Do?

  1. Check if you have this product:
    Lot #: a) 031115-3, Exp. 12/24/2019; b) 031115-3, Exp. 12/24/2019 c) 031115-3, Exp. 12/24/2019; 050815-3, Exp. 04/14/2020; d) 010716-1, 010716-6, Exp. 11/10/2018; 030116-4, Exp. 12/04/2018; 031115-2, Exp. 12/24/2019; 060116-9, Exp. 4/28/2019; 080416-1, 080416-4, Exp. 06/05/2019; 080615-4, Exp. 07/29/2020; 112015-6, Exp. 10/7/2018; 121916-7, Exp. 11/10/2018; e) 080615-5, Exp. 07/29/2020; 010716-4, 010716-5, Exp. 11/10/2018; 030116-2, Exp. 12/04/2018; 031115-5, Exp. 12/24/2019; 060116-1, 060116-4, 060116-5, Exp. 04/28/2019; 080416-1, 080416-2, exp. 06/05/2019; 112015-1, Exp. 10/07/2018; 121916-2,121916-3, 121916-6, Exp. 11/02/2019; f) 112015-5, Exp. 10/07/2018; 010716-1, Exp. 11/10/2018; 030116-3, Exp. 12/04/2018; 010716-1, 010716-2, 010716-3, 010716-8, Exp. 11/10/2018; 030116-1, 030116-3, 030116-4,030116-5, Exp. 12/4/2018; 031115-5, Exp. 12/24/2019; 060116-4, 060116-6, 060116-8, 060116-9, Exp. 04/28/2019; 080416-3, 080416-4, 080416-5, Exp. 06/05/2019; 112015-2, 112015-3, 112015-4,112015-6, 112015-7, Exp. 10/07/2018; 121916-1, Exp. 11/02/2019; 121916-3, 121916-4, 121916-5, 121916-7 121916-8, Exp.11/02/2019; g) 060116-2, 060116-3 060116-7, Exp. 04/28/2019.
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
American Pharmaceutical Ingredients LLC
Reason for Recall:
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full Description:

Progesterone USP (Micronized) (Yam) for prescription compounding, packaged in a) 1g (NDC 58597-8471-1); b) 10g (NDC 58597-8471-3); c) 25g (NDC 58597-8471-4); d) 100g (NDC 58597-8471-6); e) 500g (NDC 58597-8471-7); f) 1000g (NDC 58597-8471-8); g) 5000g (NDC 58597-8471-9), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327

Product Codes/Lot Numbers:

Lot #: a) 031115-3, Exp. 12/24/2019; b) 031115-3, Exp. 12/24/2019 c) 031115-3, Exp. 12/24/2019; 050815-3, Exp. 04/14/2020; d) 010716-1, 010716-6, Exp. 11/10/2018; 030116-4, Exp. 12/04/2018; 031115-2, Exp. 12/24/2019; 060116-9, Exp. 4/28/2019; 080416-1, 080416-4, Exp. 06/05/2019; 080615-4, Exp. 07/29/2020; 112015-6, Exp. 10/7/2018; 121916-7, Exp. 11/10/2018; e) 080615-5, Exp. 07/29/2020; 010716-4, 010716-5, Exp. 11/10/2018; 030116-2, Exp. 12/04/2018; 031115-5, Exp. 12/24/2019; 060116-1, 060116-4, 060116-5, Exp. 04/28/2019; 080416-1, 080416-2, exp. 06/05/2019; 112015-1, Exp. 10/07/2018; 121916-2,121916-3, 121916-6, Exp. 11/02/2019; f) 112015-5, Exp. 10/07/2018; 010716-1, Exp. 11/10/2018; 030116-3, Exp. 12/04/2018; 010716-1, 010716-2, 010716-3, 010716-8, Exp. 11/10/2018; 030116-1, 030116-3, 030116-4,030116-5, Exp. 12/4/2018; 031115-5, Exp. 12/24/2019; 060116-4, 060116-6, 060116-8, 060116-9, Exp. 04/28/2019; 080416-3, 080416-4, 080416-5, Exp. 06/05/2019; 112015-2, 112015-3, 112015-4,112015-6, 112015-7, Exp. 10/07/2018; 121916-1, Exp. 11/02/2019; 121916-3, 121916-4, 121916-5, 121916-7 121916-8, Exp.11/02/2019; g) 060116-2, 060116-3 060116-7, Exp. 04/28/2019.

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: D-0518-2018

Related Recalls

Nifedipine USP for prescription compounding, packaged in a) 5g (NDC 58597-8025-2); b) 25g (NDC 58597-8025-4); c) 100g (NDC 58597-8025-6); d) 500g (NDC 58597-8025-7), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327

American Pharmaceutical Ingredients

Class I - Dangerous

CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.

Feb 9, 2018 Prescription Drugs Nationwide View Details →