Class II · Moderate risk
Propranolol Hydrochloride Tablets
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Propranolol HCl
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
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.
Cause type: cGMP deviation
Departures from current Good Manufacturing Practice found in production or during FDA inspection. A broad quality-system cause: the batch was made under conditions that fall short of FDA manufacturing standards. All cgmp deviation recalls.
What was recalled
Propranolol HCl, NET WT 1 Kg, Rx Only, S.I.M.S. , Chemical Product for Medicines Preparation, Made in Italy, NDC 012660-0004
Drug: Propranolol
- Recalling firm
- Gyma Laboratories Of Amer,Inc
- Origin
- NY, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0022-2015 · FDA notice
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.
Other Propranolol recalls
See all
Class II · Moderate risk
Propranolol Hydrochloride Injection
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.
Class II · Moderate risk
Propranolol Hydrochloride Tablets
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.
Class II · Moderate risk
Propranolol HCL
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.
Class II · Moderate risk
Propranolol HCL ER
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.
Other recalls by Gyma Laboratories Of Amer,Inc
All 2014 recalls
Class II · Moderate risk
Clonidine HCL
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.
Class II · Moderate risk
Clonidine Base Micronized
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.
Class II · Moderate risk
Dipyridamole API
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.
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