Class II · Moderate risk
Tretinoin Capsules
Failed Dissolution Specifications; Low Out of specification (OOS) results for dissolution.
Tretinoin Capsules
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Failed Dissolution Specifications; Low Out of Specification (OOS) results for dissolution.
Cause type: Dissolution failure
The tablet or capsule did not dissolve within specification. Dissolution controls how much drug the body absorbs; a failure can change the effective dose. All dissolution failure recalls.
What was recalled
Tretinoin Capsules, 10 mg, Rx Only, 100 capsules per bottle, Teva Pharmaceuticals USA Inc., North Wales, PA, 19454, NDC 0555-0808-02.
Affected NDC
0555-0808-02
Compare with the code on your package — it is the most precise check available.
Drug: Tretinoin
- Recalling firm
- Teva Pharmaceuticals USA Inc
- NDC code
- 0555-0808-02
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1156-2022 · 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 Tretinoin recalls
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Class II · Moderate risk
Formula 82M
Lack of Processing Controls (lack of assurance of conformity to specifications).
Class II · Moderate risk
Formula 82F
Lack of Processing Controls (lack of assurance of conformity to specifications).
Class II · Moderate risk
Tretinoin 0.1% in Versabase Cream 0.1% Versabase CR 45 gm jar
Lack of Processing Control
Class II · Moderate risk
Tretinoin USP for prescription compounding
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
Other recalls by Teva Pharmaceuticals USA Inc
All 2022 recalls
Class II · Moderate risk
traZODone Hydrochloride Tablets
Presence of Foreign Tablets/Capsules
Class II · Moderate risk
Octreotide Acetate for Injectable Suspension
Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the contract manufacturer.
Class II · Moderate risk
Claravis (isotretinoin capsule, USP)
Failed Impurities/Degradation Specifications: Out of specification for specific impurity Tretinoin
Class II · Moderate risk
Clonidine Transdermal System
CGMP Deviations: use of an unapproved raw material
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