The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0536-2018·Announced 2018-02-28

Biotin USP Recalled for Lack of Stability Data and Controls

American Pharmaceutical Ingredients LLC is recalling Biotin USP for prescription compounding due to CGMP deviations, specifically a lack of stability data and controls to support expiration dates.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, which is a reasonable probability of temporary or medically reversible adverse health consequences. The hazard is a CGMP deviation regarding stability data, which is a quality control issue rather than a direct contamination or mislabeling of a common allergen.

Plain-English summary

American Pharmaceutical Ingredients LLC is recalling Biotin USP (Vitamin H) for prescription compounding. The product is available in 500mg, 1g, 5g, and 25g packages and is packed by American Pharmaceutical Ingredients LLC in Waterford, Michigan. The recall involves a total of 7,255 g of the product.

The recall is due to Current Good Manufacturing Practice (CGMP) deviations. Specifically, the firm lacked stability data and controls to support the assigned retest or expiration dates in its container/closure system. This means the manufacturer did not have sufficient evidence to guarantee the product's stability over its labeled shelf life.

The affected lots are distributed nationwide within the USA. The specific lot numbers and expiration dates are: Lot 070815-2 (Exp. 04/24/2018) for 500mg, 1g, and 5g packages; Lot 110416-2 (Exp. 06/30/2019) for 5g packages; and Lot 110416-1 (Exp. 06/30/2019) and Lot 070815-1 (Exp. 04/24/2018) for 25g packages. Consumers and healthcare providers should stop using the product and contact their pharmacist or the recalling firm for instructions.

The recalled product

Product
Biotin USP (Vitamin H) for prescription compounding, packaged in a) 500mg (NDC 58597-8142-1); b) 1g (NDC 58597-8142-2); c) 5g (NDC 58597-8142-3); d ) 25g (NDC 58597-8142-4), Rx only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
Manufacturer
American Pharmaceutical Ingredients LLC
Category
Drug — Pharmaceutical Ingredient
Hazard
Affected units
7,255

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (9)

  • Lot #: a) 070815-2
  • Exp. 04/24/2018
  • b) 070815-2
  • c) 070815-2
  • 110416-2
  • Exp. 06/30/2019
  • d) 110416-1
  • 070815-1
  • Exp. 04/24/2018.

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 66 recalled by American Pharmaceutical Ingredients LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 66 products in this recall →

Related recalls

Same manufacturer · American Pharmaceutical Ingredients LLC

See all →

Same hazard · cgmp deviation

See all →

Similar recalls