Class II
Terminated
Cyclobenzaprine HCl USP for prescription compounding, packaged in a) 25g (NDC 58597-8011-4), b)100g (NDC 58597-8011-6); c) 500 g (NDC 58597-8011-7); d)1000g (NDC 58597-8011-8), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
This recall has been terminated (originally issued February 28, 2018).
- Recall Initiated
- February 9, 2018
- Posted
- February 28, 2018
- Recall Number
- D-0481-2018
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 123900 g
- Firm Location
- Waterford, MI, United States
- Official Source
- View on FDA website ↗
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.
Distribution
Nationwide within USA.
Lot / Code Info
Lot #: a) 081715-1, Exp. 2/29/2020; b) 010615-1, Exp. 6/30/2019; 051616-1, Exp.11/30/2020; 081715-1, Exp. 2/29/2020; CBP1307004BVP-4102015, Exp. 4/30/2018; c) 010615-1, Exp. 6/30/2019; 081715-1, Exp. 2/29/2020 d) 010615-1, Exp. 6/30/2019; 051616-1, Exp.11/30/2020; 081715-1, Exp. 2/29/2020; 081715-2, Exp. 2/29/2020;
More recalls by American Pharmaceutical Ingredients Llc
Sermorelin Acetate, powder, a) 1 GM-bottle (NDC58597-8092-1) b) 5 GM-bottle (NDC 58597-8092-2) c) 10...
Mar 21, 2018 · Class II
Methocarbamol, USP, packaged in a) 100 g container (NDC: 58597-8023-6, b) 500 g container (NDC: 5859...
Jul 12, 2017 · Class II
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