Class II · Moderate risk
Baclofen Tablets USP
Presence of Foreign Tablets/Capsules
Gablofen (baclofen injection)
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Failed Impurities/Degradation Specification -This recall is being initiated as a precaution due to the presence of an unknown impurity observed during shelf life of the product.
Cause type: Impurity / degradation
An impurity or degradation product above its limit - other than nitrosamines. Unexpected substances in a batch can make it unsafe or less effective, even when the active ingredient is present. All impurity / degradation recalls.
What was recalled
Gablofen (baclofen injection), 50 mcg/mL, Single Use Syringe, Rx only, packaged in a box containing one 1 mL syringe, Distributed by: Primal Critical Care, Inc., 3950 Schelden Circle Bethlehem, PA, 18017, NDC 66794-151-01
Affected NDC
66794-0151-01
Compare with the code on your package — it is the most precise check available.
Drug: Baclofen
Product details
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 |
|---|---|---|---|---|
| Gablofen Baclofen Injection NDC 66794-0151 |
BACLOFEN 50 ug/mL | Injection, Solution Intrathecal |
Piramal Critical Care Inc | Rx |
- Recalling firm
- Piramal Critical Care, Inc.
- NDC code
- 66794-151-01
- Origin
- PA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1742-2019 · 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 Baclofen recalls
See all
Class I · High risk
Class I · High risk
Class I · High risk
Class I · High risk
Bupivacaine Hcl-Baclofen Pf Injectable 40mg-4000mcg/Ml
Non-Sterility
Other recalls by Piramal Critical Care, Inc.
All 2019 recalls
Class II · Moderate risk
Rocuronium Bromide Injection 50mg/5 mL
Labeling: Label Lacks Warning or Rx Legend: Finished product did not include the statement on the flip cap vial, "WARNING: PARALYZING AGENT"
Class II · Moderate risk
Sevoflurane
Failed pH Specifications: product was too acidic.
Free recall alerts
Know the day your medication is recalled
Tell us what you take. When FDA posts a recall announcement or classifies a recall for one of your medications, we email you in plain English, with what to check. No account needed.