The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0882-2017·Announced 2017-06-14

Spectrum Chemical Recalls Levonorgestrel API Due to CGMP Deviations

Spectrum Laboratory Products is recalling levonorgestrel active pharmaceutical ingredient due to manufacturing deviations found by the FDA.

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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The source explicitly identifies this as an FDA Class II recall. Per the rubric, FDA Class II recalls are classified as Severe (Score 4), particularly when involving significant manufacturing deviations that could impact product quality.

Plain-English summary

Spectrum Laboratory Products, Inc. is recalling levonorgestrel, U.S.P. active pharmaceutical ingredient, packaged in 1 kg containers. The product is prescription-only and was distributed nationwide in the USA. The specific lot number is 2FD0376, with an expiration date of 02/21/21.

The recall was initiated because the active pharmaceutical ingredient manufacturer issued a recall notice regarding deviations from current Good Manufacturing Practices (CGMP). These deviations were identified during a recent FDA inspection. The products subject to this recall were repackaged and redistributed by Spectrum Laboratory Products.

This recall is classified as FDA Class II. Consumers and healthcare providers should check their inventory for this specific product code and lot number. If found, the product should be returned to the supplier or disposed of according to local regulations.

The recalled product

Product
Levonorgestrel, U.S.P. active pharmaceutical ingredient, packaged in 1 kg container, Rx only, Spectrum Chemical Mfg. Corp, Gardena, CA 90248, New Brunswick, NJ 08901, Product code L1229.
Manufacturer
Spectrum Laboratory Products, Inc.
Category
Drug — Active Pharmaceutical Ingredient
Hazard
Affected units
1

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 (2)

  • Lot #: 2FD0376
  • Exp 02/21/21

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by Spectrum Laboratory Products, Inc. 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 2 products in this recall →

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