Class II · Moderate risk
Doxycycline Hyclate USP for prescription compounding
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
National Drug Code
Is NDC 58597-8082-07 recalled?
Doxycycline Hyclate USP for prescription compounding
Yes — this exact package was recalled
2 FDA recalls name the code 58597-8082-07 directly. A recall still applies to particular lot numbers — compare the lot on your package with the FDA notice below, and talk to your pharmacist before stopping a prescribed medication.
This code is not in the current FDA NDC directory — usual for a product that has since been discontinued or repackaged. The details below come from the recall notices themselves.
Recalls naming this package
Class II · Moderate risk
Doxycycline Hyclate USP
Labeling: Not Elsewhere Classified. Manufacturer and product were discovered to be on FDA Import Alert 66-66 for misbranding of active pharmaceutical ingredient.
Where to find this code. The NDC is printed on the pharmacy label and on the manufacturer's carton, usually as three groups of digits after “NDC”. The last group is the package size — two bottles of the same medicine can differ only in that group, and a recall may cover one but not the other.
Other recalled products from this labeler
- 58597-8049 See recall 2
- 58597-8142 See recall 2
- 58597-0077 See recall 1
- 58597-0078 See recall 1
- 58597-0079 See recall 1
- 58597-0081 See recall 1
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