FDA Recalls Misoprostol Tablets Due to Potential Labeling Mixup
Aidapak Services, LLC is recalling Misoprostol 200 mcg tablets because they may be mislabeled as Propranolol HCl or Sodium Chloride.
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, which corresponds to a Severe rating under the rubric. The hazard involves a significant labeling error where a prescription drug is mislabeled as a different medication, posing a risk of incorrect treatment.
Plain-English summary
Aidapak Services, LLC is recalling Misoprostol, Tablet, 200 mcg, NDC 59762500801, due to a labeling mixup. The recall involves 120-tablet packages of the prescription drug.
The FDA has identified that the Misoprostol tablets may be potentially mislabeled as Propranolol HCl, Tablet, 10 mg, or Sodium Chloride, Tablet, 1 mg. The specific pedigree codes associated with the recalled Misoprostol are AD21965_13 (expiration 5/1/2014) and W003117 (expiration 6/13/2014). The repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Consumers and healthcare providers should check their inventory for the specific NDC and pedigree codes listed above. If the product is found, it should be returned to the distributor or disposed of according to local regulations. Patients should consult their healthcare provider if they have questions regarding their medication.
The recalled product
- Product
- MISOPROSTOL, Tablet, 200 mcg, Rx only, Distributed by: AidaPak Service, LLC, NDC 59762500801
- Manufacturer
- Aidapak Services, LLC
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 120
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 (6)
- MISOPROSTOL
- Tablet
- 200 mcg has the following codes Pedigree: AD21965_13
- EXP: 5/1/2014
- Pedigree: W003117
- EXP: 6/13/2014.
Distribution
Part of a larger recall action
This product is one of 273 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.
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