FDA Recalls Mislabeling of Propranolol HCL Tablets
Aidapak Services is recalling 2,299 Propranolol HCL 10 mg tablets due to potential mislabeling as other medications.
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, and the rubric specifies that FDA Class II recalls with potential for significant harm (such as mislabeling leading to incorrect medication administration) are rated as Severe.
Plain-English summary
Aidapak Services, LLC is recalling 2,299 tablets of Propranolol HCL 10 mg, prescription only, due to a labeling error. The recall is classified as FDA Class II. The affected product was distributed by AidaPak Service, LLC under NDC 23155011001.
The recall was initiated because the Propranolol HCL tablets may be potentially mislabeled as other medications, including Perphenazine 16 mg, bupropion HCl ER 150 mg, and Multivitamin/Multimineral Low Iron tablets. The source text lists specific pedigree codes and expiration dates for the affected Propranolol lots, as well as the codes for the medications with which they may be confused.
The repacked drugs were distributed in Arizona, California, Oregon, and Washington. Consumers and healthcare providers should check their inventory for the specific pedigree codes and expiration dates listed in the recall notice. If the product is found, it should be returned to the distributor or disposed of according to local regulations.
The recalled product
- Product
- PROPRANOLOL HCL Tablet, 10 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 23155011001
- Manufacturer
- Aidapak Services, LLC
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 2,299
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 (20)
- PROPRANOLOL HCL Tablet
- 10 mg has the following codes Pedigree: AD21790_34
- EXP: 5/1/2014
- Pedigree: AD52390_1
- EXP: 5/17/2014
- Pedigree: AD60272_37
- EXP: 5/22/2014
- Pedigree: W002732
- EXP: 6/6/2014
- Pedigree: W003229
- EXP: 6/17/2014
- Pedigree: AD60272_34
- Pedigree: W003684
- EXP: 6/25/2014
- Pedigree: W002618
- EXP: 6/4/2014
- Pedigree: W003002
- EXP: 6/11/2014
- Pedigree: W003068
- EXP: 6/12/2014
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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