Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Cause type: Temperature excursion
The product was stored or shipped outside its labeled temperature range. Heat or freezing can degrade a drug without any visible change, so it may be weaker than labeled. All temperature excursion recalls.
Propranolol Hydrochloride Tablets, 20 mg, 100 Tablets per bottle, Rx only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Ahmedabad 382213, India; Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807. NDC: 69238-2078-1
Compare with the code on your package — it is the most precise check available.
Drug: Propranolol
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Propranolol Hydrochloride NDC 69238-2078 |
20 mg/1 | Tablet Oral |
Amneal Pharmaceuticals NY LLC | Rx |
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
CGMP Deviations: Citations given to API supplier by the Italian Health Agency AIFA for several critical deficiencies which caused a recall of the API lot used to manufacture Propanolo HCl Injection.
cGMP Deviations: GYMA laboratories Inc. has recalled multiple Active Pharmaceutical Ingredients manufactured in Italy upon receipt of a Rapid Alert Notification issued by The Italian Medicines Agency due to lack of good manufacturing practices.
Failed Tablet/Capsule Specification: Teva is recalling certain lots of Propanolol HCl Tablets, 10 mg due to the potential of some tablets not conforming to weight specification.
Labeling: Label Mixup: PROPRANOLOL HCL, Tablet, 10 mg may have potentially been mislabeled as one of the following drugs: LORazepam, Tablet, 0.25 mg (1/2 of 0.5 mg), NDC 00591024001, Pedigree: AD60243_1, EXP: 5/22/2014; PROPRANOLOL HCL, Tablet, 10 mg, NDC 23155011001, Pedigree: W003068, EXP: 6/12/2014.
Labeling: Label Mixup: PROPRANOLOL HCL ER, Capsule, 60 mg may have potentially been mislabeled as the following drug: CINACALCET HCL, Tablet, 30 mg, NDC 55513007330, Pedigree: AD52778_82, EXP: 5/21/2014.
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
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