The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-979-2014·Announced 2014-01-29

Aidapak Recalls Minocycline Capsules Due to Potential Label Mixup

Aidapak Services, LLC is recalling Minocycline HCL capsules that may have been mislabeled as Progesterone. The repacked drugs were distributed in four western states.

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 recall is classified as FDA Class II. According to the rubric, an FDA Class II recall with potential for adverse health consequences (such as taking the wrong medication) corresponds to a severity score of 4 (Severe).

Plain-English summary

Aidapak Services, LLC is recalling Minocycline HCL, Capsule, 100 mg (NDC 00591569550) due to a potential label mixup. The source text indicates that the Minocycline capsules may have been mislabeled as Progesterone, Capsule, 100 mg (NDC 00591396401). The affected Minocycline product has the pedigree AD73611_10 and an expiration date of 5/30/2014.

The repacked drugs were distributed in Arizona, California, Oregon, and Washington. The recall is classified as FDA Class II, which indicates that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

Consumers and healthcare providers should check their inventory for Minocycline HCL capsules with the specified pedigree and expiration date. If found, they should stop using the product and contact the recalling firm or their supplier for instructions on return or disposal.

The recalled product

Product
MINOCYCLINE HCL, Capsule, 100 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00591569550.
Affected units
50

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 (4)

  • MINOCYCLINE HCL
  • Capsule
  • 100 mg has the following codes: Pedigree: AD73611_10
  • EXP: 5/30/2014.

Distribution

Distributed in 4 states:

Part of a larger recall action

This product is one of 265 recalled by Aidapak Services, 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 265 products in this recall →

Same manufacturer · Aidapak Services, LLC

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